Value through Innovation27 July 2016

Clinical Study Results

  • AGGRENOX ® - Healthy
    Clinical Study Number 9.197
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Drug-Drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox ® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-Label, Randomized, Crossover Study)

    Study Document Trial synopsis 9.197_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.127
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and safety of Asasantin extended release (RAD-SP) 200/25 mg capsules b.i.d. in randomised, double-blind, placebo­ controlled study in Japanese healthy male volunteers

    Study Document Trial synopsis 9.127_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.130
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, two-period, cross over trial to compare the effects of acetylsalicylic acid (75 mg/day) with the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) (bd) on serum thromboxane B2 formation and platelet aggregation in healthy volunteers

    Study Document Trial synopsis 9.130_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.131
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability of a two week treatment with Asasantin extended release 200/25 mg capsules b.i.d, compared to reduced dose during the first week of treatment in a double-blind, randomised, placebo controlled parallel group comparison trial in healthy female and male subjects

    Study Document Trial synopsis 9.131_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.136
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Impact of food on pharmacokinetics and pharmacodynamics of Asasantin extended release (ER) 200/25 mg capsules b.i.d. in a randomized, open, 2-way cross-over study in healthy subjects.

    Study Document Trial synopsis 9.136_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.138
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Comparison of pharmacokinetics of dipyridamole in Asasantin extended release (ER) 200/25 mg capsules bid and in a combination of Persantin immediate release tablets (100 mg qid) and ASA tablets (25 mg bid) in an open, randomized, 2-way crossover study in healthy subjects.

    Study Document Trial synopsis 9.138_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.142
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Mechanism of dipyridamole action in platelets: in-vivo study with healthy volunteers

    Study Document Trial synopsis 9.142 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.144
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, 3-way cross-over study to compare the pharmacokinetics of dipyridamole in three different Asasantin ER extended release (ER) 200 mg dipyridamole/25 mg ASA formulations in healthy male and female volunteers.

    Study Document Trial synopsis 9.144 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.146
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase IV
    Study Title

    Comparison of pharmacokinetics of dipyridamole administered as Aggrenox® (dipyridamole extended release plus aspirin) capsule versus dipyridamole immediate release plus aspirin following alteration of stomach pH by the prior administration of a proton-pump inhibitor: An open-label 2-way randomized cross-over study in healthy male and female subjects age 40-65.

    Study Document Trial synopsis 9.146_CO english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.149
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a new Asasantin capsule formulation (extended release combination 200 mg Dipyridamole/25 mg ASA) compared to the commercially available Asasantin capsule formulation (Aggrenox®; extended release combination 200 mg dipyridamole/25 mg ASA) following multiple oral administration at steady state after a run-inphase (Persantine ER BID for 2 days each: 25 mg, 50 mg, 100 mg; 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [AsasantinER]) - an open label, randomized, multiple-dose, two-way crossover,change-over study in healthy male and female volunteers.

    Study Document Trial synopsis 9.149 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.158
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of dipyridamole after Asasantin (extended release 200 mg dipyridamole/25mg ASA) in 3 experimental formulations (given b.i.d. over 3 or 5 days, respectively) relative to the standard formulation in 16 healthy female and male subjects. Intraindividual comparison, randomised, open.

    Study Document Trial synopsis 9.158 english
  • AGGRENOX ® - Healthy
    Clinical Study Number 9.163
    Study Indication Healthy
    Product AGGRENOX ®
    Generic Name Dipyridamole + Acetylsalicylic acid
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability of dipyridamole of Asasantin p.o. (extended release 200 mg dipyridamole/25 mg ASA) in three experimental formulations (given BID over 3 days each) relative to the standard formulation aftera run-in phase (Persantine ER BID for 2 days each: 25 mg, 50 mg,100 mg; 150 mg [Persantine®]; 200 mg Persantine /25 mg ASA [Asasantin ER] in healthy male subjects. Four-way, change-over,randomised, open

    Study Document Trial synopsis 9.163 english
  • ALESION ® - Healthy
    Clinical Study Number 262.252
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    A trial in Healthy Volunteers of the Relative Bioavailability of Epinastine Syrup, a New Galenic Form, compared to the Reference Product Tablets

    Study Document Trial synopsis 262.252_CO english
  • ALESION ® - Healthy
    Clinical Study Number 262.255
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    Study of the pharmacokinetic interactions and relative bioavailability of epinastine and pseudoephedrine in healthy volunteers, comparing tablets containing the fixed combination of the two substances with tablets containing each of the two substances separately

    Study Document Trial synopsis 262.255_CO english
  • ALESION ® - Healthy
    Clinical Study Number 262.261
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled single increasing dose tolerance study in healthy male volunteers after intranasal application of Epinastine Nasal (dosage: 0.035 mg (0.025% solution)- 0.42 mg (0.3 % solution))

    Study Document Trial synopsis 262.261 english
  • ALESION ® - Healthy
    Clinical Study Number 262.284
    Study Indication Healthy
    Product ALESION ®
    Generic Name Epinastine
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 20 mg of the new formulation of WAL 801 CL dry syrup compared to 20 mg of the conventional formulation of WAL 801CL dry syrup following oral administration in healthy male volunteers (an open-label, randomised, single-dose, 2x2 crossover study)

    Study Document Trial synopsis 262.284_CO english
  • ANTISTAX ® - Healthy
    Clinical Study Number 1138.9
    Study Indication Healthy
    Product ANTISTAX ®
    Generic Name Vinitis vinifera
    Lab Code
    Clinical Phase I
    Study Title

    An open, uncontrolled trial in healthy volunteers to explore the plasma and urinary pharmacokinetics of a single oral dose of 1,800 mg Red Vine Leaf Extract (Antistax®)

    Study Document Trial synopsis 1138.9_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.10
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label study, in healthy adult volunteers, to determine the effects of single-dose and steady-state TPV/RTV500/200 mg on the steady-state pharmacokinetics of fluconazole100 mg qd (200 mg loading dose)

    Study Document Trial synopsis 1182.10_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.100
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, single-site, one-sequence cross-over study to assess the Relative Bioavailability of TPV/r 500 mg/200 mg at steady state whenTPV and RTV are administered as oral solutions vs. capsules in the fed and fasted state

    Study Document Trial synopsis 1182.100_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.101
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Evaluating the effects of Tipranavir (with ritonavir) capsule and liquid formulation on cytochrome P450 and P-glycoprotein activity using a biomarker cocktail in healthy human volunteers

    Study Document Trial synopsis 1182.101_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.102
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study to assess the effects of steady-state Efavirenz 600 mg QD (Sustiva®) on Tipranavir concentration whenTipranavir/Ritonavir are administered at doses 500 mg/200 mg BID to steady-state in healthy adult volunteers

    Study Document Trial synopsis 1182.102_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.104
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label one-sequence cross-over pharmacokinetic interaction study of steady-state tipranavir/ritonavir 500/200 mg with single-dose valaciclovir (500 mg) in healthy volunteers

    Study Document Trial synopsis 1182.104_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.11
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to determine the effects of single-dose and steady-state TPV/r(500 mg/200 mg) on the steady-state pharmacokinetics of Clarithromycin (BIAXIN ®) 500 mg bid and a preliminary assessment of the effects of a standard high-fat test meal on the steady-state pharmacokinetics of Tipranavir

    Study Document Trial synopsis 1182.11_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.117
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Effects of steady state Tipranavir/ritonavir or Darunavir/ritonavir or Ritonaviron platelet function, coagulation and fibrinolysis biomarkers in healthy subjects

    Study Document Trial synopsis 1182.117_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.124
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of two different oral solutions of 500 mg of tipranavir (new formulation vs. current formulation) administered in combination with 200 mg of ritonavir (oral solution) to healthy volunteers (an open-label, randomised,single-dose, two-way crossover study)

    Study Document Trial synopsis 1182.124 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.21
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Two-way Pharmacokinetic Interaction Study of Single-Dose Atorvastatin (LIPITOR®) with Tipranavir/Ritonavir (500 mg/200 mg) at Steady-State and the Effect of Antacid (MAALOX®) on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir(500 mg/200 mg) in Healthy Volunteers

    Study Document Trial synopsis 1182.21_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.22
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label, randomized, parallel group, multiple dose comparison of the effect of Tipranavir 750 mg and Ritonavir 200 mg or Tipranavir 500 mg and Ritonavir 100 mg, administered twice daily, on the pharmacokinetic characteristics of Norethindrone-Ethinyl Estradiol (Ortho®-1/35) administered as a single dose, in healthy female adult volunteers

    Study Document Trial synopsis 1182.22_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.24
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I multiple oral dose trial of Tipranavir 500 mg/Ritonavir200 mg dosed to steady-state followed by single-dose14C-radiolabeled Tipranavir co-administered with Tipranavir 500 mg/Ritonavir 200 mg to characterize the excretion balance and metabolite profile of 14C-radiolabeled Tipranavir in healthy male subjects

    Study Document Trial synopsis 1182.24_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.26
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study of multiple doses of tipranavir 500 mg and ritonavir 200 mg (twice daily) on the pharmacokinetic characteristics of methadone administered as a single dose in healthy volunteers.

    Study Document Trial synopsis 1182.26_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.42
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, parallel group study of the drug-drug pharmacokinetic interaction of steady state tipranavir (SEDDS SEC) 500 mg and ritonavir (soft gelatin capsules) 100 mg or tipranavir750 mg and ritonavir 200 mg, both bid for 13.5 days with single dose didanosine 400 mg (delayed release capsule EC beadlets) in healthy volunteers

    Study Document Trial synopsis 1182.42 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.44
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to determine the effects of steady-state TPV/r (500 mg/200 mg) on the single-dose pharmacokinetics of rifabutin (MYCOBUTIN®) 150 mg, and the effects of single-dose rifabutin (150mg) on the steady-state pharmacokinetics ofTPV 500 mg (co-administered with RTV 200 mg)

    Study Document Trial synopsis 1182.44_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.45
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 500/200 mg of tipranavir/ritonavir paediatric solution compared to 500/200 mg of tipranavir/ritonavir capsules following oral administration and bioavailability of 500/200 mg tipranavir/ritonavir paediatric solution under the influence of food in healthy female and male subjects. An open-label, randomised,single-dose, three-way crossover trial.

    Study Document Trial synopsis 1182.45 english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.46
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg r Tipranavir 750 mg and Ritonavir 200 mg twice a day for 11.5 dayson the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers

    Study Document Trial synopsis 1182.46_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.5
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An Open-label, Parallel Group, Multiple-dose Investigation of the Pharmacokinetics of Tipranavir Soft Elastic Capsules SEDDS and Ritonavir Soft Gel Capsules and Their Effects on Cytochrome P-450 (3A4) Activity in Normal Healthy Volunteers

    Study Document Trial synopsis 1182.5_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.55
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    The pharmacodynamic/pharmacokinetic interaction of tipranavir and ritonavir with loperamide in healthy volunteers

    Study Document Trial synopsis 1182.55_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.60
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of electrophysiological effects of tipranavir co-administered with ritonavir given b.i.d. for 2.5 days on the QT interval in healthy female and male subjects. A double-blind, randomised, placebo controlled, two-way crossover study with a positive control (moxifloxacin) and parallel dose roups

    Study Document Trial synopsis 1182.60_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.61
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre open-label study in healthy adult volunteers to assess the pharmacokinetic interactions between steady-state TPV (500 mg) and single-dose and steady-state atazanavir (300 mg QD) in the presence of ritonavir (100 mg)

    Study Document Trial synopsis 1182.61_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.80
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single centre, open-label study with healthy adult volunteers to determine the effects of single-dose and steady-state TPV/r 500/200 mg on the steady-state pharmacokinetics of carbamazepine (200 mg twice daily)

    Study Document Trial synopsis 1182.80_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.83
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of single-dose oral tadalafil pharmacokinetic characteristics when simultaneously co-administered with single-doseand steady-state tipranavir/ritonavir 500 mg/200 mg to healthy male volunteers

    Study Document Trial synopsis 1182.83_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.84
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, open-label study in healthy adult volunteers to determine the effects of multiple-dose omeprazole (ANTRA® 40 mgqd) on the single-dose pharmacokinetics of tipranavir 500 mg coadministered with ritonavir 200 mg

    Study Document Trial synopsis 1182.84_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.93
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, single-dose, two-way crossover bioequivalence study assessing subjects receiving tipranavir 500 mg storedat controlled temperature (test product 30°C/70% RH) compared with tipranavir 500 mg stored at controlled refrigerated conditions (reference product 2-8°C), orally co-administered with ritonavir 200 mg under fasting conditions to healthy male and female volunteers

    Study Document Trial synopsis 1182.93_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.41
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg, Administered Daily on 3 Non-Consecutive Days and Twice Daily for 7 Days, on the Pharmacokinetic Characteristics of Efavirenz (Sustiva®) 600 mg a Day in Healthy Adult Volunteers

    Study Document Trial synopsis 1182.41_CO english
  • APTIVUS ® - Healthy
    Clinical Study Number 1182.37
    Study Indication Healthy
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg twice a day for 11.5 days on the Pharmacokinetic Characteristics of Zidovudine 300 mg in Healthy Volunteers

    Study Document Trial synopsis 1182.37_CO english
  • Amelubant - Healthy
    Clinical Study Number 543.1
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability, biological effects and preliminary pharmacokinetics of increasing single oral doses of BIIL 284 BS (dose range: 0.025 mg- 75 mg PSE solution, 25 mg, 75 mg, 250 mg and 750 mg WIF tablets) in healthy male volunteers as well as food effects at 75 mg (WIF tablet).

    Study Document Trial synopsis 543.1 english
  • Amelubant - Healthy
    Clinical Study Number 543.16
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of Metabolism and Pharmacokinetics of [14C] BIIL 284 BS After Administration of a Single Oral Dose of 25 mg [ 14C] BIIL 284 BS in 6 Healthy Volunteers

    Study Document Trial snyopsis 543.16_CO english
  • Amelubant - Healthy
    Clinical Study Number 543.24
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Male Subjects (A randomized, double-blind, placebo-controlled, two period, two-way cross-over study)

    Study Document Trial synopsis 543.24_CO english
  • Amelubant - Healthy
    Clinical Study Number 543.28
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 4-way cross-over phase I study to investigate the relative bioavailability of BIIL 284 BS 75 mg boli in comparison to tablet C in fasted condition and after ingestion of a standardised meal in healthy volunteers.

    Study Document Trial synopsis 543.28 english
  • Amelubant - Healthy
    Clinical Study Number 543.3
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 3-way cross-over phase I study to investigate the relative bioavailability of BIIL 284 BS 75 mg tablet C and tablet D in comparison to WIF tablet in healthy volunteers.

    Study Document Trial synopsis 543.3 english
  • Amelubant - Healthy
    Clinical Study Number 543.31
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised, open-label, two-way crossover study in male healthy volunteers to investigate the relative bioavailability of BIIL 284 BS 5 mg Tablet FF in comparison to Tablet C after ingestion of a standardised meal.

    Study Document Trial synopsis 543.31_CO english
  • Amelubant - Healthy
    Clinical Study Number 543.4
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability, biological effects and preliminary pharmacokinetics of increasing repeated oral doses (9 days dosing) of BIIL 284 BS (doses: 25 mg, 150 mg, 250 mg as WIF tablets) in healthy male volunteers.

    Study Document Trial synopsis 543.4 english
  • Amelubant - Healthy
    Clinical Study Number 543.5
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    Randomised 3-way cross-over phase I study to investigate the effect of different food compositions (low fat and high fat meal) on bioavailability of BIIL 284 BS 75 mg tablet in healthy male volunteers.

    Study Document Trial synopsis 543.5 english
  • Amelubant - Healthy
    Clinical Study Number 543.7
    Study Indication Healthy
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Effects of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of a Single Dose of Theophylline in Healthy Male Volunteers (A Randomized, Double-Blind, Placebo­ Controlled, Two-period, Two-way Crossover Study)

    Study Document Trial synopsis 543.7_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.1
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacodynamics and pharmacokinetics of single rising inhaled BEA 2180 BR doses (2.5 µg to 1600 µg administered with the Respimat®) in healthy male subjects, alone and followed by methacholine challenge. A randomised, double-blind within dose group, placebo-controlled study, with a 36 µg tiotropium bromide single dose sub-study (open, two-fold crossover).

    Study Document Trial synopsis 1205.1_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.2
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising inhalative doses (20 µg, 50 µg, 100 µg, 200 µg, and 400 µg) of BEA 2180 BR for 21 days in healthy male volunteers (double-blind, randomised, placebo controlled [at each dose level] study)

    Study Document Trial synopsis 1205.2_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.5
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising intravenous doses (2.5 µg, 7.5 µg, 25 µg, 50 µg, 100 µg, 200 µg, 350 µg, 500 µg free cation) BEA 2180 BR in healthy male volunteers with an additional arm by inhalation in one dose group (1600 µg)

    Study Document Trial synopsis 1205.5 english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.8
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of 1200 µg (free cation)[14C] BEA 2180 BR administered orally compared to 500 µg (free cation) [14C] BEA 2180 BR administered intravenously in healthy male volunteers in an open label, single-dose and parallel study design

    Study Document Trial synopsis 1205.8_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.18
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability and pharmacokinetics of multiple rising inhalative doses (50 µg, 100 µg and 200 µg q.d. for 14 days) of BEA 2180 BR in Japanese healthy male volunteers

    Study Document Trial synopsis 1205.18_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.20
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising peroral doses (400, 800, 1200 µg free cation) BEA 2180 BR in healthy male volunteers.

    Study Document Trial synopsis 1205.20_CO english
  • BI 1015550 - Healthy
    Clinical Study Number 1305.1
    Study Indication Healthy
    Product BI 1015550
    Generic Name BI 1015550
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 1015550 in healthy male volunteers (a partially randomised, partially single-blind, placebo-controlled phase I study)

    Study Document Trial synopsis 1305.1_DS english
  • BI 1015550 - Healthy
    Clinical Study Number 1305.2
    Study Indication Healthy
    Product BI 1015550
    Generic Name BI 1015550
    Lab Code BI 1015550
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 1015550 powder for oral solution in healthy male volunteers q.d. or b.i.d.for 14 days (a randomised, double-blind, placebo-controlled within dose groups Phase I trial)

    Study Document Trial synopsis 1305.2 english
  • BI 1034020 - Healthy
    Clinical Study Number 1312.1
    Study Indication Healthy
    Product BI 1034020
    Generic Name BI 1034020
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising intravenous and subcutaneous doses of BI 1034020 in healthy male volunteers (partially randomised, single-blind, placebo-controlled within dose groups, clinical phase I study)

    Study Document Trial statement 1312.1_DR english Trial synopsis 1312.1_DR english
  • BI 11054 - Healthy
    Clinical Study Number 1250.1
    Study Indication Healthy
    Product BI 11054
    Generic Name BI 11054
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to assess safety, tolerability, and pharmacokinetics of single rising inhaled doses (0.5 µg to 70 µg administered with Respimat®) of BI 11054 CL in healthy male volunteers

    Study Document Trial synopsis 1250.1 english
  • BI 113823 - Healthy
    Clinical Study Number 1272.1
    Study Indication Healthy
    Product BI 113823
    Generic Name BI 113823
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of safety, tolerability and pharmacokinetics of single rising oral doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and tablet administered to healthy male volunteers in a partially randomised and double-blinded, placebo-controlled phase I trial. Including intra-individual open comparisons of PiB and tablet (fasted and fed)

    Study Document Trial synopsis 1272.1_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.1
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of 5, 10, 25, 50, 100, 200 and 400 mg BI 11634 solution administered to healthy male volunteers. Randomised, double-blind, placebo controlled at each dose level. Intra-individual comparison of solution to an immediate release tablet formulation at one dose level (50mg)

    Study Document Trial synopsis 1234.1_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.12
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 10 mg BI 11634 immediate release tablet (IR) compared to 10 mg of oral solution following oral administration in healthy male volunteers (open-label, single-dose, intra-individual comparison); determination of pharmacokinetics of 5 mg, 10 mg and 25 mg IR-tablet formulation (open-label, single dose)

    Study Document Trial synopsis 1234.12_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.2
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple, rising oral doses of 2.5 mg, 5 mg, 7.5 mg, and 10 mg BI 11634 oral solution administered t.i.d. for 5 days to healthy male volunteers; randomised, double-blind, placebo-controlled at each dose level

    Study Document Trial synopsis 1234.2_CO english
  • BI 11634 - Healthy
    Clinical Study Number 1234.7
    Study Indication Healthy
    Product BI 11634
    Generic Name BI 11634
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomised, single-dose, four-way cross-over formulation finding study of the oral bioavailability of four prototype extended release formulations with 25 mg BI 11634, and intra-individual comparison to immediate-release tablets (25 mg) in healthy male volunteers

    Study Document Trial synopsis 1234.7 english
  • BI 1181181 - Healthy
    Clinical Study Number 1344.2
    Study Indication Healthy
    Product BI 1181181
    Generic Name BI 1181181
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 1181181 given orally q.d. for 10 days in young healthy male and elderly healthy male/female volunteers (randomized, double-blind, placebo controlled within dose groups, Phase I study)

    Study Document Trial statement 1344.2 english
  • BI 135585 - Healthy
    Clinical Study Number 1283.1
    Study Indication Healthy
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of 10 mg to 1200 mg of BI 135585 XX administered as a solution to healthy male volunteers (trial part 1), followed by an open, randomised, single-dose, intra-individual bioavailability comparison of 200 mg BI 135585 XX as tabletand as solution (trial part 2)

    Study Document Trial synopsis 1283.1 english
  • BI 135585 - Healthy
    Clinical Study Number 1283.3
    Study Indication Healthy
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase I
    Study Title

    Bioavailability and pharmacokinetics of 50 mg BI 135585 XX administered as tablet with and without food to healthy male volunteers (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 1283.3 english
  • BI 135585 - Healthy
    Clinical Study Number 1283.34
    Study Indication Healthy
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of BI 135585 XX administered as oral dose in healthy male volunteers (open-label, single-dose trial)

    Study Document Trial synopsis 1283.34 english
  • BI 137882 - Healthy
    Clinical Study Number 1306.1
    Study Indication Healthy
    Product BI 137882
    Generic Name BI 137882
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 137882 in healthy male volunteers (A randomised, single-blind, placebo-controlled Phase I study)

    Study Document Trial statement 1306.1_CO english Trial synopsis 1306.1_DS_DR english
  • BI 14332 - Healthy
    Clinical Study Number 1233.1
    Study Indication Healthy
    Product BI 14332
    Generic Name BI 14332
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (0.5 mg to 200 mg) of BI 14332 CL as powder in the bottle reconstituted with 0.1% tartaric acid administered to healthy male subjects. A randomised and placebo-controlled trial, double blinded within dose groups.

    Study Document Trial synopsis 1233.1 english
  • BI 14332 - Healthy
    Clinical Study Number 1233.2
    Study Indication Healthy
    Product BI 14332
    Generic Name BI 14332
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses (0.5, 2.5, 10 and 20 mg q.d. for 10 days) of BI 14332 CL as tablet in female and male patients with type 2 diabetes (randomised, double-blind, placebo-controlled within the dose groups), followed by a 4-week treatment part* (randomised, double-blind, placebo-controlled) of two doses (planned 5 and 20 mg) selected on the basis of tolerability and DPP-4 inhibition in the multiple rising dose (part* 4-week treatment part was not performed)

    Study Document Trial synopsis 1233.2_CO english
  • BI 14332 - Healthy
    Clinical Study Number 1233.3
    Study Indication Healthy
    Product BI 14332
    Generic Name BI 14332
    Lab Code
    Clinical Phase I
    Study Title

    Influence of a standardised high fat breakfast on the bioavailability of 10 mg BI 14332 CL taken as two tablets of 5 mg q.d. in healthy male volunteers (an open-label, randomised, single-dose, two-way crossover trial)

    Study Document Trial synopsis 1233.3_CO english
  • BI 224436 - Healthy
    Clinical Study Number 1277.1
    Study Indication Healthy
    Product BI 224436
    Generic Name BI 224436
    Lab Code
    Clinical Phase I
    Study Title

    Safety and pharmacokinetics of single rising oral doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and1200 mg dose levels in healthy male volunteers (randomized, double-blind,placebo-controlled within dose groups). 

    Study Document Trial synopsis 1277.1_CO english
  • BI 34021 - Healthy
    Clinical Study Number 1258.1
    Study Indication Healthy
    Product BI 34021
    Generic Name BI 34021
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BI 34021 FU2 oral drinking solution in healthy male volunteers (dose range: 5 - 500 mg). A double-blind (within dose groups), randomised, placebo-controlled within dose groups,single-rising dose study, including re-dosing at 50 mg and 150 mg (food effect) and at 100 mg (two 50 mg tablets)

    Study Document Trial synopsis 1258.1 english
  • BI 411034 - Healthy
    Clinical Study Number 1308.1
    Study Indication Healthy
    Product BI 411034
    Generic Name n/a
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 411034 in healthy male volunteers (randomised, single-blind, placebo-controlled within dose groups, phase I study)

    Study Document Trial synopsis 1308.1_DR english
  • BI 416970 - Healthy
    Clinical Study Number 1345.1
    Study Indication Healthy
    Product BI 416970
    Generic Name BI 416970
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 416970 in healthy male volunteers in a partially randomised, single-blind, placebo-controlled trial

    Study Document Trial synopsis 1345.1_DR english
  • BI 44370 - Healthy
    Clinical Study Number 1246.1
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BI 44370 TA oral drinking solution in healthy male volunteers (dose range: 5 - 800 mg). A double-blind (within dose groups), randomised, placebo-controlled within dose groups, single rising dose study, including re-dosing at 100 mg and 500 mg (solution) and at 200 mg (four 50 mg tablets).

    Study Document Trial synopsis 1246.1 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.12
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising intravenous doses (10 to 50 mg) of BI 44370 BS solution in healthy male volunteers (randomised, single-blind, placebo-controlled within dosegroups, Phase I)

    Study Document Trial synopsis 1246.12 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.14
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    A phase I trial to investigate the metabolism and pharmacokinetics of an open label single dose of 200 mg [14C]-BI 44370 BS administered as an oral solution in healthy male volunteers

    Study Document Trial synopsis 1246.14_CO english
  • BI 44370 - Healthy
    Clinical Study Number 1246.15
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 44370 TA tablets (100 mg, 200 mg and 300 mg three times every two hours on one day and q.d. for another 2 to 3 days) in healthy male and female volunteers, a randomised, double-blind, placebo-controlled within dose groups Phase I study

    Study Document Trial synopsis 1246.15 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.2
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets (100 mg as two 50 mg tablets) with and without a high fat meal in healthy male and female volunteers: a single dose, open-label, randomised, six-way cross-over trial

    Study Document Trial synopsis 1246.2 english
  • BI 44370 - Healthy
    Clinical Study Number 1246.3
    Study Indication Healthy
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Effects of 100 mg and 500 mg BI 44370 TA orally applied as 50 mg tablets on the pharmacokinetics of 2 mg orally administered midazolam solution. An open-label, randomised, parallel group, fixed-sequence study with intra-individual comparison of midazolam pharmacokinetics with and without BI 44370 TA

    Study Document Trial synopsis 1246.3 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.1
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (2.5 mg to 1200 mg) of BI 44847 as powder in the bottle reconstituted with 0.2% natrosol solution administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blinded trial

    Study Document Trial synopsis 1224.1 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.11
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (50 mg to 800 mg) of BI 44847 as tablet(s) administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blinded trial.

    Study Document Trial synopsis 1224.11_CO english
  • BI 44847 - Healthy
    Clinical Study Number 1224.2
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of 400 mg BI 44847 as suspension compared to 400 mg BI 44847 as tablet and the influence of food (standardised high fat breakfast) on the tablet in a single dose, open label, randomised three-way crossover trial and relative oral bioavailability of 40 mg BI 44847 as solution compared to 40 mg BI 44847 as tablet in healthy male volunteers in a single dose, open-label, randomised two-way crossover trial.

    Study Document Trial synopsis 1224.2 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.22
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Evaluation of relative bioavailability of BI 44847 in different ethnic groups (subjects of white, Asian, and African origin), and evaluation of effect of diet and a carbose coadministration on bioavailability following oral administration of 200 mg BI 44847 in healthy male volunteers. An open-label, single-dose, parallel-group, phase I study (group 1 with additional crossover aspects)

    Study Document Trial synopsis 1224.22_CO english
  • BI 54903 - Healthy
    Clinical Study Number 1256.1
    Study Indication Healthy
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising inhalative doses (delivered doses of 23 to 69 µg q.d. and 69 µg b.i.d. for four days) of butylated hydroxytoluene (an excipient novel for inhalation administration) via Respimat® Soft Mist TM Inhaler B (randomised,double-blind, placebo-controlled sub-study 1) and safety, tolerability and pharmacokinetics of multiple rising inhalative doses (fine particle doses of 160 to 1280 µg q.d. for 10 days) of BI 54903 XX via Respimat® Soft Mist TM Inhaler B as randomised, double-blind, placebo-controlled Phase I trial in healthy male volunteers (main study) and comparison of systemic exposure following a single fine particle dose of 640 µg BI 54903 XX via Respimat® Soft Mist TM Inhaler B and of a single fine particle dose of 640 µg Alvesco® (ciclesonide) via MDI (randomised,open-label, two-way crossover sub-study 2)

    Study Document Trial synopsis 1256.1 english
  • BI 54903 - Healthy
    Clinical Study Number 1256.2
    Study Indication Healthy
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase I
    Study Title

    A single-blind, randomised, two-way crossover Phase I study to assess safety, tolerability and pharmacokinetics of the fixed dose combination of BI 1744 CL plus BI 54903 XX via Respimat® B versus the free combination of BI 1744 CL via Respimat® A and BI 54903 XX via Respimat® B in healthy male and female volunteers

    Study Document Trial synopsis 1256.2 english
  • BI 54903 - Healthy
    Clinical Study Number 1256.3
    Study Indication Healthy
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, three-way cross over Phase I study to assess safety, tolerability and pharmacokinetics of the fixed dose combination of BI 1744 CL plus BI 54903 XX via Respimat® B versus the mono products of BI 1744 CL via Respimat® A and BI 54903 XX via Respimat® B in healthy male and female volunteers

    Study Document Trial synopsis 1256.3 english
  • BI 638683 - Healthy
    Clinical Study Number 1279.1
    Study Indication Healthy
    Product BI 638683
    Generic Name BI 638683
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (1-700 mg) of BI 638683 Powder in bottle (PiB) in healthy male volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1279.1 english
  • BI 653048 - Healthy
    Clinical Study Number 1262.1
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BI 653048 H3PO4 oral drinking solution in healthy male volunteers (dose range: 0.1 mg –1500 mg). A single-blind (within dose groups), randomised, placebo controlled within dose groups, single rising dose Phase I study

    Study Document Trial synopsis 1262.1 english
  • BI 653048 - Healthy
    Clinical Study Number 1262.2
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers) of BI 653048 BS H3PO4 capsule formulation administered as multiple doses of 25 mg to 200 mg qd for 10 days. A randomised, double-blind within dose groups, placebo-controlled, multiple rising dose trial with open-label active comparator

    Study Document Trial synopsis 1262.2_CO english
  • BI 653048 - Healthy
    Clinical Study Number 1262.9
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacodynamics and pharmacokinetics of a BI 653048 BS H3PO4 capsule formulation administered as multiple doses of 25 mg to 200 mg once daily (qd) for 3 days assessing pharmacodynamics as endotoxin-induced inflammatory response of asingle intravenous bolus administration of 2 ng/kg body weight lipopolysaccharide (LPS). A randomised, double-blind within dose groups, placebo-controlled, multiple rising dose phase I trial with open label active comparator in healthy male subjects

    Study Document Trial synopsis 1262.9_CO english
  • BI 653048 - Healthy
    Clinical Study Number 1267.1
    Study Indication Healthy
    Product BI 653048
    Generic Name BI 653048
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of 0.25, 0.5, 1, 2, 4, 20, 50, 100, 150 and 200 mg BI 60732 Powder in Bottle (PIB) administered to healthy male volunteers in a randomised, double blind, placebo controlled phase I trial. 

    Study Document Trial synopsis 1267.1_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.56
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of different salt forms and formulations of single doses either 50 or 200 mg BI 671800 in the fasted or fed state. An open-label, randomised, Phase I study with a 3-period crossover followed by two treatment periods in fixed sequence in healthy male and female volunteers

    Study Document Trial synopsis 1268.56_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.59
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BI 671800 HEA given200 mg b.i.d. or 400 mg b.i.d. over 7 days. A randomised, doubleblind, placebo controlled within dose groups Phase I study in healthy male and female volunteers

    Study Document Trial synopsis 1268.59 english
  • BI 671800 - Healthy
    Clinical Study Number 1268.60
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of single doses of 200 mg BI 671800 HEA administered orally as a delayed release (enteric coated) tablet; or via the EnterionTM capsule as solution to the jejunum, ascending colon or descending colon; or via the EnterionTM capsule as particulate to the ascending colon. An open-label, five periods, fixed sequence phase I study in healthy male volunteers

    Study Document Trial synopsis 1268.60_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.7
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    A phase I trial to investigate the metabolism and pharmacokinetics ofan open-label single dose of 400 mg [14C] BI 671800 HEA administered as an oral solution of the choline salt in healthy male volunteers

    Study Document Trial synopsis 1268.7_CO english
  • BI 671800 - Healthy
    Clinical Study Number 1268.15
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind (within dose groups), parallel group, placebocontrolledphase I study to evaluate the safety, tolerability and pharmacokineticsof single rising doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinesehealthy male volunteers and multiple rising doses (50 mg b.i.d., 200 mg b.i.d.,400 mg b.i.d.) of BI 671800 HEA in Japanese healthy male volunteers

    Study Document Trial synopsis 1268.15 english
  • BI 671800 - Healthy
    Clinical Study Number 1268.4
    Study Indication Healthy
    Product BI 671800
    Generic Name BI 671800
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of different salt forms and different extended release formulations of single doses of either 50 or 200 mg BI 671800 in the fasted or fed state. An open-label, randomised, Phase I study with a 5-way crossover followed by two treatment periods in fixed sequence in healthy male and female volunteers

    Study Document Trial statement 1268.4_DR english
  • BI 691751 - Healthy
    Clinical Study Number 1334.2
    Study Indication Healthy
    Product BI 691751
    Generic Name BI 691751
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of BI 691751 in healthy male subjects

    Study Document Trial statement 1334.2 english Trial synopsis 1334.2 english
  • BI 691751 - Healthy
    Clinical Study Number 1334.1
    Study Indication Healthy
    Product BI 691751
    Generic Name BI 691751
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising oral doses of BI 691751 in healthy male volunteers in a randomised, single blind, placebo-controlled design (part I) and investigation of relative bioavailability of BI 691751 given as tablet and oral solution to healthy male subjects in an open, randomised, single-dose, single period parallel group design (part II)

    Study Document Trial synopsis 1334.1_DR english
  • BI 691751 - Healthy
    Clinical Study Number 1334.10
    Study Indication Healthy
    Product BI 691751
    Generic Name BI 691751
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of BI 691751 when administered alone or in combination with multiple oral doses of itraconazole in healthy male subjects (an open-label, randomised, two-period, two-sequence crossover study)

    Study Document Trial synopsis 1334.10_DR english
  • BI 691751 - Healthy
    Clinical Study Number 1334.5
    Study Indication Healthy
    Product BI 691751
    Generic Name BI 691751
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses of BI 691751 in healthy Asian male volunteers in a randomised, double-blind, placebo-controlled design

    Study Document Trial synopsis 1334.5 english
  • BIBB 1464 - Healthy
    Clinical Study Number 1178.1
    Study Indication Healthy
    Product BIBB 1464
    Generic Name BIBB 1464
    Lab Code
    Clinical Phase I
    Study Title

    Safety/Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg Or 2 mg Or 6 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

    Study Document Trial synopsis 1178.1 english
  • BIBB 1464 - Healthy
    Clinical Study Number 1178.2
    Study Indication Healthy
    Product BIBB 1464
    Generic Name BIBB 1464
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamics, preliminary pharmacokinetics and tolerability after multiple oral doses of 0.25 mg, 0.5 mg and 1 mg o.d. BIBB 1464 (tablet) or pravastatin 20 mg over 2 weeks in hyperlipemic healthy male subjects (parallel group comparison, randomized, placebo controlled, partly double blind [pravastatin open]).

    Study Document Trial synopsis 1178.2 english
  • BIBB 515 - Healthy
    Clinical Study Number 525.3
    Study Indication Healthy
    Product BIBB 515
    Generic Name BIBB 515
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamics, preliminary pharmacokinetics and tolerability after multiple oral doses of 2.5 mg o.d. BIBB 515 BS (capsule) or pravastatin 20 mg over 2 weeks in hyperlipemic healthy male subjects (parallel group comparison, randomized, placebo controlled, partly double blind [pravastatin open]).

    Study Document Trial synopsis 525.3 english
  • BIBB 515 - Healthy
    Clinical Study Number 525.4
    Study Indication Healthy
    Product BIBB 515
    Generic Name BIBB 515
    Lab Code
    Clinical Phase I
    Study Title

    Single-dose pharmacokinetics of 2.5 mg BIBB 515 BS and effect of food after oral administration of capsules to healthy subjects (randomized, 2-way-cross-over, open study).

    Study Document Trial synopsis 525.4 english
  • BIBP 5371 - Healthy
    Clinical Study Number 1214.1
    Study Indication Healthy
    Product BIBP 5371
    Generic Name BIBP 5371
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BIBP 5371 CL followingoral administration to healthy male and female volunteers (dose range:10 – 350 mg). A double-blind (within treatment groups), randomised,placebo-controlled, single rising dose study, including comparisons of50 mg vs. 100 mg tablet and tablet vs. drinking solution, andinvestigation of food effect.

    Study Document Trial synopsis 1214.1 english
  • BIBT 1011 - Healthy
    Clinical Study Number 1193.1
    Study Indication Healthy
    Product BIBT 1011
    Generic Name BIBT 1011
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacodynamics, and pharmacokinetics after single oral administration of 1, 5, 10, 30,100,200 and 400 mg BIBT 1011 BS as drinking solution in healthy subjects. An open, placebo­ controlled, randomised study, double blind at each dose level.

    Study Document Trial synopsis 1193.1 english
  • BIBT 986 - Healthy
    Clinical Study Number 1192.1
    Study Indication Healthy
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability and pharmacokinetics/-dynamics of single rising dosesof 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986BS (IV infusion over 30 minutes) in healthy male subjects. Placebo controlled, double blind randomised at each dose level

    Study Document Trial synopsis 1192.1_CO english
  • BIBT 986 - Healthy
    Clinical Study Number 1192.11
    Study Indication Healthy
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of 0.9, 2.25 or 4.5 mg of BIBT 986 over 1 hour, followed by 0.2, 0.5 or 1.0 mg/hours of BIBT 986 for 7 hours given as IV infusion on tissue factor triggered coagulation in a randomised, placebo controlled, dose escalation design in healthy male volunteers

    Study Document Trial synopsis 1192.11_CO english
  • BIBT 986 - Healthy
    Clinical Study Number 1192.2
    Study Indication Healthy
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability and pharmacokinetics/-dynamics of 0.5 mg and 1.0 mg(actual 0.8 mg) of BIBT 986 BS per hour given as IV infusion over 32 hours in healthy male subjects. Placebo controlled, double blind randomised at each dose level

    Study Document Trial synopsis 1192.2_CO english
  • BIBW 2948 - Healthy
    Clinical Study Number 1219.1
    Study Indication Healthy
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability and pharmacokinetics of single rising inhaled doses BIBW 2948 BS (0.75 to 150 mg inhalation powder, hard capsule for HandiHaler®) in healthy male volunteers.

    Study Document Trial synopsis 1219.1 english
  • BIBW 2948 - Healthy
    Clinical Study Number 1219.3
    Study Indication Healthy
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising inhaled doses (7.5 to 60 mg daily for 12 days) of BIBW 2948 BS inhalation powder, hard capsule for HandiHaler® in healthy male volunteers (randomised, double-blind placebo-controlled within dose groups)

    Study Document Trial synopsis 1219.3 english
  • BIBX 245 - Healthy
    Clinical Study Number 537.7
    Study Indication Healthy
    Product BIBX 245
    Generic Name BIBX 245
    Lab Code
    Clinical Phase I
    Study Title

    Single-dose pharmacokinetics of 160 mg BIBX 245 CL and effectof food after oral administration of tablets to healthy subjects (randomized, 2-way-cross-over, open study).

    Study Document Trial synopsis 537.7 english
  • BILB 1941 - Healthy
    Clinical Study Number 1201.1
    Study Indication Healthy
    Product BILB 1941
    Generic Name BILB 1941
    Lab Code
    Clinical Phase I
    Study Title

    Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg,20 mg, 60 mg, 120 mg, 200 mg, 300 mg, 600 mg, 1000 mg, 1500 mg,2000 mg, 2400 mg, and 3000 mg BILB 1941 ZW (PEG 400/TRISsolution) in Healthy Male Subjects, in a Randomised Double Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Three-Way Crossover Bioavailability Comparison of 600 mg BILB 1941 ZW in a PEG 400/TRIS solution and 600 mg BILB 1941 ZW tablet and 600 mg BILB 1941 ZW tablet administered with Food.

    Study Document Trial synopsis 1201.1 english
  • BILR 355 - Healthy
    Clinical Study Number 1188.1
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo-controlled single increasing dose safety, tolerability and preliminary pharmacokinetics study in healthy male volunteers after oral administration of BILR 355 BS solved in PEG 400 (dosage: 1 - 200 mg)

    Study Document Trial synopsis 1188.1 english
  • BILR 355 - Healthy
    Clinical Study Number 1188.10
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetic Interaction Study of BILR 355 BS Plus Ritonavir with Truvada

    Study Document Trial synopsis 1188.10_CO english
  • BILR 355 - Healthy
    Clinical Study Number 1188.32
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Open Label, Single Dose Escalation Trial of BILR 355 (SDS) Plus Ritonavir in Healthy Volunteers

    Study Document Trial synopsis 1188.32_CO english
  • BILR 355 - Healthy
    Clinical Study Number 1188.33
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Open Label Relative Bioavilability Study of Tablet and Capsules of SDS Formulations in Healthy Volunteers

    Study Document Trial synopsis 1188.33_CO english
  • BILR 355 - Healthy
    Clinical Study Number 1188.4
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    An open study to investigate the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of single doses of BILR 355 BS (dose steps: 5 and 12.5 mg) solved in 5 ml PEG 400 after oral administration in healthy male volunteers

    Study Document Trial synopsis 1188.4 english
  • BILR 355 - Healthy
    Clinical Study Number 1188.5
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Single Dose Relative Bioavailability of BILR 355 BS newTablet and suspension formulations compared to current 1b formulation

    Study Document Trial synopsis 1188.5_CO english
  • BILR 355 - Healthy
    Clinical Study Number 1188.6
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    An open study to investigate the effect of different boosting agents on pharmacokinetics of single doses of BILR 355 BS (dose steps: 5 and 12.5 mg) dissolved in 5 mL PEG 400 after oral administration in healthy male volunteers

    Study Document Trial synopsis 1188.6 english
  • BILR 355 - Healthy
    Clinical Study Number 1188.7
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinietic interaction trial between tipranivir plus ritonavir and BILR 355 BS

    Study Document Trial synopsis 1188.7_CO english
  • BILR 355 - Healthy
    Clinical Study Number 1188.8
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Trial of Pharmacokinetic Interaction between Lopinivir plus ritonavir and BILR 355 BS

    Study Document Trial synopsis 1188.8_CO english
  • BILR 355 - Healthy
    Clinical Study Number 1188.9
    Study Indication Healthy
    Product BILR 355
    Generic Name BILR 355
    Lab Code
    Clinical Phase I
    Study Title

    Study of Pharmacokinetic Interaction between Combivir (ZDV+3TC) and BILR 355 BS plus ritaonavir

    Study Document Trial synopsis 1188.9_CO english
  • BIRB 1017 - Healthy
    Clinical Study Number 1187.1
    Study Indication Healthy
    Product BIRB 1017
    Generic Name BIRB 1017
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses of BIRB 1017 BS (5, 25, 100, 250, 500, and 800 mg) as a solution in PEG 400 / 26% ethanol administered to healthy male subjects. Placebo controlled and blinded at each dose level 

    Study Document Trial synopsis 1187.1 english
  • BIRT 1696 - Healthy
    Clinical Study Number 1195.1
    Study Indication Healthy
    Product BIRT 1696
    Generic Name BIRT 1696
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics and pharmacodynamics of single rising oral doses of BIRT 1696 BS as a solution (10, 100, 400, 1000, 2000, 3000 mg) in 15 ml PEG 400 to healthy human subjects. A three part study: part 1 placebo-controlled, randomised, dose escalating double blinded within each dose level; part 2 open label grapefruit juice effect in 100 mg dose level group; part 3 open label food effect in 400 mg dose level group.

    Study Document Trial synopsis 1195.1_CO english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.10
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    A study to evaluate the effect of multiple doses of 500 mg of BIRT 2584 XX tablets on the pharmacokinetic parameters of warfarin, omeprazole, caffeine, and dextromethorphan dosed orally and midazolam dosed IV, in healthy male volunteers

    Study Document Trial synopsis 1206.10_CO english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.12
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    A study to evaluate the effect of a single oral dose and multiple oral doses of 500 mg of BIRT 2584 XX tablets on the pharmacokinetic parameters of amitriptyline and nortriptyline in healthy male and female subjects

    Study Document Trial synopsis 1206.12_CO english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.2
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX administered as multiple doses of 100 mg to 750 mg qd for 14 or 28 days (randomised, double-blind placebo controlled design), and safety and pharmacokinetics of 500 mg of BIRT 2584 XX administered with and without food as single dose (open, intra-individual comparison) to healthy male volunteers.

    Study Document Trial synopsis 1206.2 english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.9
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    To investigate the effect of BIRT 2584 XX and its metabolite BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated high therapeutic dose on the PK of midazolam, a probe substrate for CYP 3A4. Midazolam PK will be measured before dosing of BIRT 2584 XX, after a single dose of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days.

    Study Document Trial synopsis 1206.9 english
  • BIRT 2584 - Healthy
    Clinical Study Number 1206.1
    Study Indication Healthy
    Product BIRT 2584
    Generic Name BIRT 2584
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics, and pharmacodynamics of single rising oral doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a solution in PEG 400 administered to healthy male volunteers. Placebo controlled and blinded at each dose level.

    Study Document Trial synopsis 1206.1 english
  • BISOLTUSSIN ® - Healthy
    Clinical Study Number 1134.2
    Study Indication Healthy
    Product BISOLTUSSIN ®
    Generic Name Dextromethorphan
    Lab Code
    Clinical Phase I
    Study Title

    A phase I, single dose, controlled two-way crossover trial to evaluate the relative bioavailability of orally administered dextromethorphan syrup (21 mg dextromethorphan hydrobromide monohydrate) in comparison to dextromethorphan soft pastilles (21 mg dextromethorphan hydrobromidemonohydrate) in healthy male and female subjects who are extensive metabolisers for cytochrome P450 (CYP) 2D6

    Study Document Trial synopsis 1134.2_CO english
  • BISOLTUSSIN ® - Healthy
    Clinical Study Number 1134.3
    Study Indication Healthy
    Product BISOLTUSSIN ®
    Generic Name Dextromethorphan
    Lab Code
    Clinical Phase I
    Study Title

    A phase I multiple dose trial to investigate safety with special emphasis on ECG effects and tolerability after oral doses of 30 mg qid and 90 mg qid dextromethorphan hydrobromide monohydrate (2 mg/mL syrup) in healthy male and female subjects for 2 days followed by a morning dose (extensive metabolisers of CYP 2D6) and for 10 days followed by a morning dose (poor metabolisers of CYP 2D6) (randomised, double-blind, placebo-controlled groups)

    Study Document Trial synopsis 1134.3_CO english
  • BISOLVON ® - Healthy
    Clinical Study Number 65.129
    Study Indication Healthy
    Product BISOLVON ®
    Generic Name Bromhexine
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of bromhexine for oral administration of 16 mg of bromhexine hydrochloride granules compared to 16 mg of bromhexine hydrochloride syrup in healthy male and female volunteers (an open-label, randomised, single-dose, replicate design Phase I study with two treatments in four crossover periods)

    Study Document Trial synopsis 65.129_DR english
  • BIWH 3 - Healthy
    Clinical Study Number 1181.2
    Study Indication Healthy
    Product BIWH 3
    Generic Name BIWH 3
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and Pharmacodynamics of BIWH 3: a randomised, placebo-controlled, double-blind dose escalation study (0.02, 0.06, 0.2,0.6, and 2.0 µg/kg intravenous over one hour) in healthy Duffy positive vs. Duffy negative male volunteers.

    Study Document Trial synopsis 1181.2_CO english
  • BUSCOFEN ® - Healthy
    Clinical Study Number 1024.7
    Study Indication Healthy
    Product BUSCOFEN ®
    Generic Name Ibuprofen
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed-dose combination tablet containing 200 mg ibuprofen and 30 mg pseudoephedrine HCl compared to RhinAdvil® (200 mg ibuprofen and 30 mg pseudoephedrine HCl) as a fixed-dose combination tablet administered in healthy male and female volunteers (open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1024.7_DR english
  • BUSCOFEN ® - Healthy
    Clinical Study Number 1024.3
    Study Indication Healthy
    Product BUSCOFEN ®
    Generic Name Ibuprofen
    Lab Code
    Clinical Phase I
    Study Title

    An open two-way cross-over study to evaluate the relative bioavailability of lbuprofen enantiomers after single p.o. administration of 200 mg syrup (T) compared with 200 mg standard Brufen® syrup (R).

    Study Document Trial synopsis 1024.3 english
  • BUSCOFEN ® - Healthy
    Clinical Study Number 1024.5
    Study Indication Healthy
    Product BUSCOFEN ®
    Generic Name Ibuprofen
    Lab Code
    Clinical Phase I
    Study Title

    Open-label, randomised, single dose, four-way crossover study to investigate the relative bioavailability of a 400 mg ibuprofen extrudate tablet compared to a 400 mg ibuprofen lysinate tablet (Dolormin extra®) and a 400 mg ibuprofen tablet (Brufen® 400 mg, Denmark), in fasted condition and after ingestion of a standardised meal in healthy male and female volunteers

    Study Document Trial synopsis 1024.5 english
  • BUSCOPAN ® - Healthy
    Clinical Study Number 202.846
    Study Indication Healthy
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability study to investigate and to compare two different formulations of hyoscine butylbromide, following oral administration in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, phase I study)

    Study Document Trial synopsis 202.846_DR english
  • BUSCOPAN ® - Healthy
    Clinical Study Number 202.833
    Study Indication Healthy
    Product BUSCOPAN ®
    Generic Name Hyoscine butylbromide
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled study to assess pharmacokinetics, safety and tolerability of single rising oral doses (20 mg,60 mg, 100 mg, 200 mg and 400 mg) and multiple rising oral doses (3 x 20 mg,3 x 60 mg and 3 x 100 mg per day) of Buscopan® in healthy male volunteers

    Study Document Trial synopsis 202.833_CO english
  • Bilberry extract - Healthy
    Clinical Study Number 1147.2
    Study Indication Healthy
    Product Bilberry extract
    Generic Name Bilberry extract
    Lab Code
    Clinical Phase II
    Study Title

    Efficacy and tolerability of a treatment over 28 days with a bilberry extract standardised to a content of 25% anthocyanidines in volunteers with impaired twilight and night vision

    Study Document Trial synopsis 1147.2 english
  • Bilberry extract - Healthy
    Clinical Study Number 1147.3
    Study Indication Healthy
    Product Bilberry extract
    Generic Name Bilberry extract
    Lab Code
    Clinical Phase II
    Study Title

    Efficacy of a bilberry extract standardised to a content of 25% anthocyanosides in improving the night vision of healthy volunteers: a double-blind, randomised, placebo-controlled, crossover trial over 2 x 28 days

    Study Document Trial synopsis 1147.3 english
  • CATAPRESAN ® - Healthy
    Clinical Study Number 253.2486
    Study Indication Healthy
    Product CATAPRESAN ®
    Generic Name Clonidine
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind study designed to assess the bioequivalence and adhesion properties of transdermal clonidine-VistanexTM compared to transdermal clonidine-Oppanol® following transdermal administration in healthy male and female volunteers

    Study Document Trial synopsis 253.2486 english
  • COMBIVENT ® - Healthy
    Clinical Study Number 1012.24
    Study Indication Healthy
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, placebo-controlled, double-blind, 3 way cross-over safety and tolerability study of single and repetitive dosing of COMBIVENT HFA compared to COMBIVENT® CFC and placebo HFA in healthy male and female subjects (cumulative dose: 1600 mcg (HFA) or 1648 mcg (CFC) of salbutamol sulfate, 288 mcg of ipratropium bromide)

    Study Document Trial synopsis 1012.24 english
  • Cilobradine - Healthy
    Clinical Study Number 503.204
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamic effects, safety and tolerability of 2 mg and 5 mg cilobradine, administered p.o. once daily over 14 days to healthy male and female volunteers in a randomised, placebo-controlled, double blind study, with an open-label uncontrolled intra-individual comparison to 400 mg moxifloxacin single dose in a subset of volunteers.

    Study Document Trial synopsis 503.204_CO english
  • Cilobradine - Healthy
    Clinical Study Number 503.209
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of [14C]-DK-AH 269 CL after administration of single doses of 5 mg [14C]-DK-AH 269 CL intravenously and 10 mg [14C]-DK-AH 269 CL as oral solution in a parallel-group design in 12 healthy male volunteers.

    Study Document Trial synopsis 503.209_CO english
  • Cilobradine - Healthy
    Clinical Study Number 503.213
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    The effect of cytochrome P 450 3A4 inhibition by itraconazole on the single oral dose pharmacokinetics of cilobradine (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 503.213_CO english
  • Cilobradine - Healthy
    Clinical Study Number 503.203
    Study Indication Healthy
    Product Cilobradine
    Generic Name Cilobradine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamic effects, safety and tolerability of 0.25 mg, 0.5 mg,1 mg and 2 mg cilobradine, compared to 190 mg metoprolol succinate and placebo, administered p.o. once daily over 14 days to healthy volunteers in a randomised, placebo-controlled, partly double blind study, with a 4 mg/14 mg and 10 mg/20 mg cilobradine single dose versus placebo substudy (double blind, three-fold crossover).

    Study Document Trial synopsis 503.203 english
  • Ciluprevir - Healthy
    Clinical Study Number 605.1
    Study Indication Healthy
    Product Ciluprevir
    Generic Name Ciluprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg,1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400:ethanol solution) in Healthy Male Subjects, Combined with Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two­ Stage Trial Design with Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part).

    Study Document Trial synopsis 605.1 english
  • Crobenetine - Healthy
    Clinical Study Number 599.1
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    A single-blind, placebo-controlled, parallel group, single increasing dose tolerance study in healthy male volunteers after intravenous administration of Bill 890 CL (dosage: 0.5 mg/h- 80 mglh), infusion time 1 hour.

    Study Document Trial synopsis 599.1_CO english
  • Crobenetine - Healthy
    Clinical Study Number 599.11
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of 50 mg desipramine daily, given orally over 7 days with and without concomitant administration of 175 mg crobenetine, given as a 6 hrs i.v. infusion (one hour loading dose directly followed by a five hours maintenance dose). A randomised, placebo controlled, single blind (for crobenetine), two-way cross over trial in healthy male subjects.

    Study Document Trial synopsis 599.11_CO english
  • Crobenetine - Healthy
    Clinical Study Number 599.12
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of 7.5 mg midazolam, given orally with and without concomitant administration of 175 mg crobenetine, given as a 6 hrs i.v. infusion (one hour loading dose directly followed by a five hours maintenance dose). A randomised, single blind, two-way crossover trial in healthy male subjects.

    Study Document Trial synopsis 599.12_CO english
  • Crobenetine - Healthy
    Clinical Study Number 599.2
    Study Indication Healthy
    Product Crobenetine
    Generic Name Crobenetine
    Lab Code
    Clinical Phase I
    Study Title

    A single blind, placebo-controlled, parallel-group, single increasing dose tolerance study in healthy young male volunteers after intravenous administration of Bill 890 CL as loading dose (dosage: 12.5, 25 and50 mg/h, infusion time 1 hour; 50 mg/h, infusion time 2 hours) followed by maintenance dose (dosage: 6.25, 12.5 and 25 mg/h, infusion time5 hours; 30 mg/h, infusion time 4 hours) and in healthy elderly male and female volunteers after intravenous administration of Bill 890 CL as loading dose (dosage: 50 mg/h, infusion time 1 hour) followed by maintenance dose (dosage: 25 mg/h, infusion time 5 hours).

    Study Document Trial synopsis 599.2_CO english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.22
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Metabolite profile, excretion balance and pharmacokinetics of BI 207127 NA combined with [14C]-BI 207127 NA in healthy adult male volunteers after an 800 mg single oral solution dose; a phase I, single-arm, open-label trial

    Study Document Trial synopsis 1241.22 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.1
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses (5 mg to 3000 mg) of BI 207127 NA as powder in the bottle reconstituted with PEG 400/Tris/SDS in healthy male subjects. A randomised, placebo-controlled and within dose groups double-blinded trial. Followed by an intra-individual, not randomised, open comparison of powder in the bottle without and with food.

    Study Document Trial synopsis 1241.1 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.9
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 207127 trial formulation II prototypes versus BI 207127 trial formulation I administered orally as tablet in single doses of 800 mg to healthy volunteers, and evaluation of the effect of food on the bioavailability of a selected prototype (an open-label, two-stage, within parts randomised six-way and two-way crossover phase I study)

    Study Document Trial synopsis 1241.9_CO english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.18
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, fixed sequence Phase I study in healthy male volunteers to assess sequentially the effects of multiple doses of BI 207127 NA, BI 201335 NA followed by the combination of BI 207127 NA and BI 201335 NA, on the single dose pharmacokinetics of midazolam and tolbutamide and on the systemic exposure of BI 207127 NA and BI 201335 NA

    Study Document Trial synopsis 1241.18_CO english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.42
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, assessor-blind, placebo and active controlled, parallel group study to assess the phototoxic potential of Faldaprevir (administered orally, once daily) for 6 days in healthy male and female subjects

    Study Document Trial synopsis 1241.42 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.8
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses (400 mg , 800 mg, 1200 mg) of BI 207127 NA in healthy male Asian volunteers and single oral dose (1200 mg) of BI 207127 NA in healthy male Caucasian volunteers (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1241.8 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.26
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 207127 FF tablets, BI 207127 FF modified tabletsand BI 207127 TFII tablets administered orally as three tablets (single dose) tohealthy male volunteers, an open-label, randomised three-way crossover study

    Study Document Trial synopsis 1241.26_DS_DR english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.31
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, two-period, fixed-sequence, phase I trial to evaluate the effect of multiple doses of BI 207127 + faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in healthy premenopausal female subjects

    Study Document Trial synopsis 1241.31 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.35
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, multiple dose study to assess safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID administered orally for 9 days (Part 1) and multiple doses of BI 207127 combined with faldaprevir administered orally for 16 days (Part 2) in healthy male and female subjects

    Study Document Trial synopsis 1241.35 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.40
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Thorough QT study to evaluate the effects of BI 207127 (Deleobuvir) combined with Faldaprevir on cardiac safety parameters in healthy female and male subjects. Randomised, placebo controlled, single-blind, three-period crossover Phase-I-study with moxifloxacin as positive control

    Study Document Trial synopsis 1241.40_DR english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.44
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food and of increased gastric pH on the relative bioavailability of deleobuvir following single oral administration in healthy Caucasian and Japanese subjects (an open-label, randomised, four-way crossover study)

    Study Document Trial synopsis 1241.44 english
  • Deleobuvir - Healthy
    Clinical Study Number 1241.61
    Study Indication Healthy
    Product Deleobuvir
    Generic Name Deleobuvir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of potential drug-drug interactions between faldaprevir and immunosuppressants (cyclosporine and tacrolimus) in healthy male and female subjects (open-label, fixed-sequence trial)

    Study Document Trial synopsis 1241.61 english
  • Doramapimod - Healthy
    Clinical Study Number 1175.1
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety, pharmacokinetics and pharmacodynamics of single rising doses (1, 4, 15, 50, 100, 200, 400, and 600 mg) oral BIRB 796 BS in healthy human subjects. A placebo controlled, randomised study, double blinded at each dose level

    Study Document Trial synopsis 1175.1 english
  • Doramapimod - Healthy
    Clinical Study Number 1175.3
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS tablets (50, 150, 300 and 600 mg) administered orally to healthy human subjects once daily for 7 days. A placebo controlled, randomised, double blinded study.

    Study Document Trial synopsis 1175.3 english
  • Doramapimod - Healthy
    Clinical Study Number 1175.4
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    The effect of single oral dose BIRB 796 BS (50 and 600 mg) on endotoxin-induced inflammatory responses in healthy human subjects. A placebo-controlled, randomised, parallel, double-blinded study.

    Study Document Trial synopsis 1175.4_CO english
  • Doramapimod - Healthy
    Clinical Study Number 1175.6
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    A phase I single oral dose (100 mg) trial to characterize the excretion balance of 14c-radiolabeled BIRB 796 BS and to determine its metabolites in normal male subjects

    Study Document Trial synopsis 1175.6_CO english
  • Doramapimod - Healthy
    Clinical Study Number 1175.14
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    Safety and pharmacokinetics of BIRB 796 BS tablets administered twice daily orally (total daily dose 30 and 60 mg) to healthy human male subjects for 14 days. A double-blind, placebo-controlled, parallel group study.

    Study Document Trial synopsis 1175.14_CO english
  • Doramapimod - Healthy
    Clinical Study Number 1175.17
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, crossover study of the bioavailability of oral BIRB 796 BS tablets (30 mg single dose) with and without administration of oral pantoprazole in healthy male volunteers to assess the effect of gastric pH on absorption of BIRB 796 BS.

    Study Document Trial synopsis 1175.17_CO english
  • Doramapimod - Healthy
    Clinical Study Number 1175.21
    Study Indication Healthy
    Product Doramapimod
    Generic Name Doramapimod
    Lab Code
    Clinical Phase I
    Study Title

    Safety and pharmacokinetics of BIRB 796 BS tablets administered twice daily orally (total daily dose 90,120,150 or 180 mg) to healthy human subjects for 14 days. A double-blind, placebo-controlled study in parallel groups for the lower two dose levels then dose escalation for 2 highest dose levels.

    Study Document Trial synopsis 1175.21_CO english
  • ESR 1150 - Healthy
    Clinical Study Number 1172.1
    Study Indication Healthy
    Product ESR 1150
    Generic Name ESR 1150
    Lab Code
    Clinical Phase I
    Study Title

    Absolute bioavailability, pharmacokinetics and safety of ESR 1150 CL 1mg capsule compared to 0.015 mg solution i.v. as single administration in healthy male subjects (open-labelled, 2-way cross-over study)

    Study Document Trial synopsis 1172.1_CO english
  • ESR 1150 - Healthy
    Clinical Study Number 1172.2
    Study Indication Healthy
    Product ESR 1150
    Generic Name ESR 1150
    Lab Code
    Clinical Phase I
    Study Title

    Administration of ESR 1150 CL in ascending doses of 0.5, 1, 2, 4 and 8 mg in an open, group comparison and placebo-controlled design (placebo randomised double blind in the dose groups) for the assessment of safety, tolerability (maximal tolerated dose, MTD), pharmacokinetics and pharmacodynamics in5 groups of 8 female and 5 male healthy subjects, and 4 mg additionally in fed state, in a cross over design (first part of study). Safety, tolerability and pharmacokinetics of MTD/4, MTD/2 and MTD in 6 healthy male subjects, identified as CYP2D6 and/or "spartein" poor metabolizers, in a 3-fold cross over, open study (second part of study)

    Study Document Trial synopsis 1172.2_CO english
  • Excipient - Healthy
    Clinical Study Number 260.3171
    Study Indication Healthy
    Product Excipient
    Generic Name Excipient
    Lab Code
    Clinical Phase I
    Study Title

    The effect of alcoholic-carrier solutions within-devices (HFA134a-MDI or Respimat®) on breath alcohol measured by Ethylometer in healthy volunteers.

    Study Document Trial synopsis 260.3171_CO english
  • FLOMAX ® - Healthy
    Clinical Study Number 527.70
    Study Indication Healthy
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    A parallel group study with three different ?-antagonists and placebo once daily over three weeks to assess their influence on the extent of weekly phenylephrine induced mydriasis at three different concentrations of phenylephrine in healthy male volunteers

    Study Document Trial synopsis 527.70 english
  • FLOMAX ® - Healthy
    Clinical Study Number 527.78
    Study Indication Healthy
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    An open label randomized two-way crossover study to investigate the effect of ketoconazole mediated CYP3A4 inhibition on the single oral dose pharmacokinetics of tamsulosin in healthy male volunteers (CYP2D6 extensive metabolizers).

    Study Document Trial synopsis 527.78 english
  • FLOMAX ® - Healthy
    Clinical Study Number 527.79
    Study Indication Healthy
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    An open label randomized two-way crossover study to investigate the effect ofparoxetine mediated CYP2D6 inhibition on the single oral dosepharmacokinetics of tamsulosin in healthy male volunteers (CYP2D6 extensivemetabolizers).

    Study Document Trial synopsis 527.79 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.59
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food and of increased gastric pH on the relative bioavailability of a single oral dose of 240 mg faldaprevir in an open-label, randomised, three-way crossover trial in healthy subjects

    Study Document Trial synopsis 1220.59 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.61
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of interactions between faldaprevir, itraconazole, atorvastatin and rosuvastatin in healthy male and female subjects (open-label, fixed-sequence)

    Study Document Trial synopsis 1220.61 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.65
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of faldaprevir effect on steady state pharmacokinetics of raltegravir in healthy male and female volunteers (an open-label trial with two periods in a fixed sequence)

    Study Document Trial synopsis 1220.65 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.20
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Effect of multiple dosing with 240mg q 12hrs BI 201335 on the pharmacokinetics of 50 mg single dose efavirenz and effect of multiple dosing with 600 mg QDefavirenz on CYP3A and the pharmacokinetics of BI 201335 in healthy volunteers

    Study Document Trial synopsis 1220.20 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.46
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 201335 (capsule) compared to three different oral solutions of BI 201335 following oral administration in healthy male and female volunteers (an open-label, randomised, single-dose, four-way crossover study)

    Study Document Trial synopsis 1220.46_DS_DR english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.49
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Effect of multiple dosing with 240 mg QD BI 201335 on the steady-state pharmacokinetics of 800 mg QD darunavir coadministered with 100 mg QD ritonavir (DRV/r) in healthy male and female volunteers (an open-label, multiple-dose, single group, single fixed sequence phase I study)

    Study Document Trial synopsis 1220.49 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.50
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Effect of multiple dosing with 240 mg BID BI 201335 on the steady state pharmacokinetics of 300mg QD Tenofovir and effect of multiple dosing with 300mg QD Tenofovir on steady state BI 201335 pharmacokinetics in healthy male and female volunteers

    Study Document Trial synopsis 1220.50 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.52
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of single and multiple oral doses of 120 mg and 240 mg faldaprevir in healthy Chinese volunteers

    Study Document Trial synopsis 1220.52 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.53
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of bioequivalence between two different formulations of BI 201335 NA soft gelatine capsules in healthy male volunteers. (an open-label, randomised, single-dose, four-period replicated crossover study)

    Study Document Trial synopsis 1220.53 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.56
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, two-period, fixed-sequence, phase I trial to evaluate the effect ofmultiple doses of 240 mg BI 201335 QD on the multiple-dose pharmacokineticsof a combination of ethinylestradiol and levonorgestrel in healthy pre menopausal female volunteers

    Study Document Trial synopsis 1220.56 english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.1
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerance, and pharmacokinetics of single oral doses of 5 mg, 20 mg, 60mg, 150 mg, 300 mg, 600 mg, 1000 mg, and 1500 mg BI 201335 ZW (PEG400/TRIS/water solution) in healthy male subjects, in a randomised double blind, placebo controlled rising dose study, followed with an open-label intrasubject two-stage crossover pilot bioavailability comparison of 600 mg BI201335 ZW in a PEG 400/TRIS/water solution co-administered with food.

    Study Document Trial synopsis 1220.1_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.3
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerance, and pharmacokinetics of single oral doses of 4 mg, 16 mg,48 mg, 120 mg, 240 mg, 480 mg, 800 mg, and 1200 mg BI 201335 NA (PEG 400/TRIS/meglumine/water solution) in healthy male subjects, in a randomised single blind, placebo controlled rising dose study, followed with an open-label intra-subject two-stage crossover pilot bioavailability comparison of 480 mg BI 201335 NA in a PEG 400/TRIS/meglumine/water solution coadministered with food

    Study Document Trial synopsis 1220.3_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.6
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising oral doses of 20 mg, 48 mg, 120 mg, and 240 mg once a day of BI 201335 NA (oral solution) in healthy male subjects, in a randomized double blind, placebo controlled study

    Study Document Trial synopsis 1220.6_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.9
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open label fixed sequence Phase I study to investigate the effect of BI 201335 mediated UGT1A1 inhibition on the multiple oral dose pharmacokinetics of raltegravir (Isentress®) in healthy male and female volunteers

    Study Document Trial synopsis 1220.9_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.10
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, crossover relative bioavailability study of a new soft gelatin capsule formulation of BI 201335 NA compared to the current solution formulation (powder in bottle (PIB)), after single dose oral administration in healthy volunteers

    Study Document Trial synopsis 1220.10_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.13
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, and pharmacokinetics of single rising oral doses (40 mg to 480 mg) of BI 201335 NA as capsule(s) administered to healthy male subjects – a randomised, placebo-controlled (within dose groups) and double-blind trial

    Study Document Trial synopsis 1220.13_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.16
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of the effect of 480 mg and 1200 mg of BI 201335 as single dose on the QT interval in healthy female and male subjects; a randomised, placebo-controlled, double-blind, four-way crossover Phase I study with moxifloxacin as positive control

    Study Document Trial synopsis 1220.16_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.32
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Evaluation of the effects of single oral dose and multiple oral doses of BI 201335 NA on Cytochrome P450 and P-glycoprotein activity using a probe drug cocktail. An open-label, single-arm Phase I study in healthy human volunteers

    Study Document Trial synopsis 1220.32_CO english
  • Faldaprevir - Healthy
    Clinical Study Number 1220.33
    Study Indication Healthy
    Product Faldaprevir
    Generic Name Faldaprevir
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of a single dose of 240 mg [14C]-BI 201335 given as oral solution to healthy male volunteers at steady state of BI 201335 NA maintained with oral capsules of 240 mg BI 201335, a phase I, single-arm, open-label trial

    Study Document Trial synopsis 1220.33_CO english
  • Figopitant - Healthy
    Clinical Study Number 1157.2
    Study Indication Healthy
    Product Figopitant
    Generic Name Figopitant
    Lab Code
    Clinical Phase I
    Study Title

    A single increasing dose safety, tolerability and pharmacodynamics (citric acid challenge) study after oral administration of BIIF 1149 BS (drinking solution; single doses: 0.1 - 25 mg) in healthy male volunteers (randomised, double-blind, placebo-controlled, parallel groups)

    Study Document Trial synopsis 1157.2 english
  • Figopitant - Healthy
    Clinical Study Number 1157.3
    Study Indication Healthy
    Product Figopitant
    Generic Name Figopitant
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (within dose groups), randomised, placebo-controlled, parallel-group study to investigate the safety, tolerability and preliminary pharmacokinetics of increasing repeated oral doses (nine days treatment of 5 mg and 10 mg and eighteen days treatment of 25 mg and 40 mg) of BIIF 1149 BS in healthy male volunteers

    Study Document Trial synopsis 1157.3_CO english
  • Figopitant - Healthy
    Clinical Study Number 1157.4
    Study Indication Healthy
    Product Figopitant
    Generic Name Figopitant
    Lab Code
    Clinical Phase I
    Study Title

    A single increasing dose safety, tolerability and pharmacodynamics (citric acid challenge) study after oral administration of BIIF 1149 BS (single doses as tablets: 40, 65, 100 mg) in healthy male volunteers (randomised, double-blind within each dose group, placebo-controlled, parallel groups)

    Study Document Trial synopsis 1157.4 english
  • GINKOBA ® - Healthy
    Clinical Study Number 1118.2
    Study Indication Healthy
    Product GINKOBA ®
    Generic Name Ginkgo leaf
    Lab Code
    Clinical Phase III
    Study Title

    Efficacy and safety of Ginkgo biloba film-coated tablets (2 x 60 mgdaily p.o.) in improving cognitive functions and neuropsychological functioning of middle-aged cognitively intact adults: a double-blind, placebo-controlled, parallel group, randomised trial.

    Study Document Trial synopsis 1118.2_CO english
  • GINSANA ® - Healthy
    Clinical Study Number 1020.10
    Study Indication Healthy
    Product GINSANA ®
    Generic Name Panax ginseng extract
    Lab Code
    Clinical Phase II
    Study Title

    Efficacy of Ginsana in improving half-time haemoglobin re-oxygenation in recreational sportspeople: a double-blind, placebo controlled pilot study

    Study Document Trial synopsis 1020.10 english
  • GINSANA ® - Healthy
    Clinical Study Number 1020.11
    Study Indication Healthy
    Product GINSANA ®
    Generic Name Panax ginseng extract
    Lab Code
    Clinical Phase II
    Study Title

    Efficacy of Ginsana® in improving half-time haemoglobin re­oxygenation in recreational sportspeople: a double-blind, placebo controlled pilot study

    Study Document Trial synopsis 1020.11 english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.151
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of 40 mg afatinib given alone compared to concomitant and timed administration of multiple oral doses of ritonavir – an open-label, randomised, three-way crossover trial in healthy male volunteers

    Study Document Trial synopsis 1200.151_DR english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.152
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of 40 mg afatinib given alone and after multiple doses of rifampicin – an open-label, two-period, fixed sequence clinical phase I trial in healthy male volunteers

    Study Document Trial synopsis 1200.152_DR english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.25
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Metabolism and pharmacokinetics of [14C]-BIBW 2992 MA2 after administration of single doses of 15 mg [14C]-BIBW 2992 MA2 oral solution in healthy male volunteers

    Study Document Trial synopsis 1200.25_CO english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.35
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single dose of 20 mg BIBW 2992 administered as tablet (final formulation) compared to BIBW 2992 drinking solution andBIBW 2992 tablet (trial formulation II) following oral administration to healthy male volunteers (an open-label, randomised, single-dose, three-way crossover phase I study)

    Study Document Trial synopsis 1200.35 english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.79
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of BIBW 2992 (20 mg) after coadministration with multiple oral doses of ritonavir (200 mg bid for 3 days) compared to the bioavailability of a single oral dose of BIBW 2992 (20 mg) alone in healthy male volunteers (an open-label, randomised, two-way crossover, clinical phase I study)

    Study Document Trial synopsis 1200.79 english
  • GIOTRIF ® (afatinib) - Healthy
    Clinical Study Number 1200.80
    Study Indication Healthy
    Product GIOTRIF ® (afatinib)
    Generic Name Afatinib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BIBW 2992 administered orally as 20 mg, 30 mg, 40 mg, and 50 mg tablets (final formulation) to healthy male volunteers in an open-label, single rising dose, Phase I trial

    Study Document Trial synopsis 1200.80 english
  • GLYXAMBI ® - Healthy
    Clinical Study Number 1275.3
    Study Indication Healthy
    Product GLYXAMBI ®
    Generic Name Empagliflozin + Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability investigations of a 25 mg BI 10773 / 5 mg linagliptin fixed dose combination (FDC) tablet (formulation A1) including the comparison with its mono-components, the comparison with a second FDC tablet (formulation A3), and the investigation of food (an open-label, randomised, single dose, crossover, Phase I trial in healthy male and female volunteers)

    Study Document Trial synopsis 1275.3_DR english
  • Irampanel - Healthy
    Clinical Study Number 600.1
    Study Indication Healthy
    Product Irampanel
    Generic Name Irampanel
    Lab Code
    Clinical Phase I
    Study Title

    A single-blind, placebo-controlled single increasing dose tolerance study in healthy male volunteers after intravenous administration of BIIR 561 CL (dosage: 1 mg/h- 175 mg/h), infusion time 1 hour.

    Study Document Trial synopsis 600.1 english
  • Irampanel - Healthy
    Clinical Study Number 600.2
    Study Indication Healthy
    Product Irampanel
    Generic Name Irampanel
    Lab Code
    Clinical Phase I
    Study Title

    A single blind, placebo-controlled single increasing dose tolerance study in healthy male volunteers after intravenous administration of BIIR 561 CL as loading dose (dosage: 37.5 mg/h- 150 mg/h, infusion time 1 hour) followed by maintenance dose (dosage: 20 mg/h-40 to125 mg/h, infusion time 5 hours)

    Study Document Trial synopsis 600.2_CO english
  • Irampanel - Healthy
    Clinical Study Number 600.6
    Study Indication Healthy
    Product Irampanel
    Generic Name Irampanel
    Lab Code
    Clinical Phase I
    Study Title

    A single-blind, placebo-controlled single dose tolerance study in healthy elderly male and female volunteers after intravenous administration of BIIR 561 CL as loading dose (dosage: 75 mg/h, infusion time 1 hour) followed by maintenance dose (dosage: 40 mg/h and 75 mg/h,infusion time 5 hours)

    Study Document Trial synopsis 600.6_CO english
  • Itasetron - Healthy
    Clinical Study Number 208.629
    Study Indication Healthy
    Product Itasetron
    Generic Name Itasetron
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effects of food on the bioavailability and pharrnacokinetic profile of Itasetron after a single oral dose of 1 mg in healthy male subjects (3-way cross-over).

    Study Document Trial synopsis 208.629 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.16
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Assessment of the effect of 25 mg and 200 mg of BI 10773 as single dose on the QT interval in healthy female and male subjects. A randomised, placebo controlled, double-blind, five-period crossover Phase-I-study with moxifloxacin as positive control

    Study Document Trial synopsis 1245.16_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.18
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and warfarin and pharmacodynamics of warfarin after co-administration compared to multiple oral doses of BI 10773 (25 mg once daily) and a single oral dose of warfarin (25 mg) alone in healthy male volunteers (an open-label, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.18_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.40
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of digoxin (0.5 mg) when administered alone or in combination with multiple oral doses of BI 10773(25 mg qd) in healthy male and female volunteers (an open-label, randomised,two-way crossover study)

    Study Document Trial synopsis 1245.40_CO english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.41
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, two-period, fixed-sequence trial to evaluate the effect of multiple doses of BI 10773 on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in healthy premenopausal female volunteers

    Study Document Trial synopsis 1245.41_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.43
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 10773 given alone and together with verapamil - an open-label, randomised, crossover trial in healthy subjects

    Study Document Trial synopsis 1245.43_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.45
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of multiple oral doses of BI 10773 (25 mg) and ramipril (5 mg) administered together compared to multiple oral doses of BI 10773 (25 mg) alone and ramipril (5 mg) alone in healthy male and female volunteers (an open-label, randomised, three-way crossover, clinical phase I study)

    Study Document Trial synopsis 1245.45_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.50
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of pioglitazone after co-administration with different doses of BI 10773 in healthy volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.50 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.51
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 25 mg BI 10773 (Final Formulation) compared to 25 mg BI 10773 XX (Trial Formulation 2) following oral administration in healthy male and female volunteers (an open-label, randomised, single-dose,two-way crossover study)

    Study Document Trial synopsis 1245.51_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.58
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of single dose BI 10773 co-administered  with multiple doses of 600 mg gemfibrozil bid compared to single dose treatment of BI 10773 alone in healthy volunteers – a phase I, open-label, randomised, 2-way crossover trial

    Study Document Trial synopsis 1245.58_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.63
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of BI 10773 and simvastatin after single and combined administration - an open-label, randomised, crossover trial in healthy subjects

    Study Document Trial synopsis 1245.63_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.79
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of food on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets in an open, randomised, single dose, three-period cross-over study in healthy male and female subjects

    Study Document Trial synopsis 1245.79_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.83
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empaglifozin
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, open-label, three-way crossover trial to investigate the effect of rifampicin and probenecid on empagliflozin pharmacokinetics in healthy male and female subjects

    Study Document Trial synopsis 1245.83_DR english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.1
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (0.5 mg to 800 mg) of BI 10773 as tablets administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blind trial

    Study Document Trial synopsis 1245.1 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.3
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    The effect of food on the bioavailability and pharmacokinetics of BI10773 tablets, administered as a single dose of 50 mg with and without food to healthy male volunteers in an open-label, randomised intraindividual crossover comparison design

    Study Document Trial synopsis 1245.3 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.6
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and metformin after co-administration compared to multiple oral doses of BI 10773 (50 mg q.d.) alone and metformin (1000 mg b.i.d.) alone to healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.6 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.7
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and glimepiride after co-coadministrationcompared to multiple oral doses of BI 10773 (50 mg q.d.) alone and a single dose of glimepiride (1 mg) alone in healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.7 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.17
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 50 mg and pioglitazone 45 mg after co-administration compared to BI 10773 and pioglitazone alone in healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.17_CO english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.27
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of both BI 10773 and sitagliptin after co-administration compared to multiple oral doses of BI 10773 (50 mg q.d.) alone and sitagliptin (100 mg q.d.) alone in healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.27 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.30
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of multiple doses BI 10773 50 mg and linagliptin 5 mg after concomitant administration compared to multiple doses of BI 10773 50 mg and linagliptin 5 mg administered alone to healthy male volunteers (an open-label, randomised, crossover, clinical phase I study)

    Study Document Trial synopsis 1245.30 english
  • JARDIANCE ® - Healthy
    Clinical Study Number 1245.5
    Study Indication Healthy
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    A Phase I, randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (1 to 100 mg) of BI 10773 in healthy male volunteers

    Study Document Trial synopsis 1245.5_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.21
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomised, single-dose, two-way crossover study in healthy male and female subjects to evaluate the bioequivalence of Jentadueto® (two fixed dose combination tablets of linagliptin 2.5 mg and metformin 500 mg) compared with the free combination of linagliptin 5 mg and metformin 1000 mg tablets under fasting conditions

    Study Document Trial synopsis 1288.21 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.11
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin/metformin extended release (2.5 mg/1000 mg) compared with the free combination of linagliptin and metformin extended release tablets in healthy subjects (an open-label, randomised, single dose, two-way crossover trial)

    Study Document Trial synopsis 1288.11_DR english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.6
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC) in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.6_DR english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.5
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Characterisation of fixed dose combination tablets of linagliptin 2.5 mg/   metformin 850 mg or linagliptin 2.5 mg/metformin 500 mg and relative oral   bioavailability compared with single linagliptin 2.5 mg and metformin 850 mg or 500 mg tablets administered together to healthy Chinese male and female   volunteers in an open-label, randomised, single-dose, two-way crossover, phase I  study

    Study Document Trial synopsis 1288.5_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.20
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of metformin under fed conditions after administration of a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination tablet compared with single linagliptin 2.5 mg and metformin 500 mg tablets administered together in healthy male and female volunteers, (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.20_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.8
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two newly developed extended release FDC tablet strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin extended release compared with the free combination of Linagliptin and Metformin extended release in healthy subjects (an open-label, randomised, single dose, two-way crossover study)

    Study Document Trial synopsis 1288.8_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.1
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet compared with single linagliptin 2.5 mg and metformin 1000 mg tablets administered together in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.1_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.2
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose combination tablet compared with single linagliptin 2.5 mg and metformin 500 mg tablets given concomitantly to healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.2 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.3
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination tablet compared with single linagliptin 2.5 mg and metformin 850 mg tablets administered together in healthy male and female volunteers (an open-label, randomised, single dose, two-way crossover, Phase I trial)

    Study Document Trial synopsis 1288.3 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.4
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet administered with and without food to healthy male and female subjects in an open, randomised, single-dose, two-way crossover, Phase I trial

    Study Document Trial synopsis 1288.4_CO english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.9
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin/metformin extended release (5 mg/1000 mg) compared with the free combination of linagliptin and metformin extended release tablets in healthy subjects (an open-label, randomised, single dose, two-way crossover trial)

    Study Document Trial synopsis 1288.9 english
  • JENTADUETO ® - Healthy
    Clinical Study Number 1288.10
    Study Indication Healthy
    Product JENTADUETO ®
    Generic Name Linagliptin + Metformin
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin/metformin extended release (2.5 mg/750 mg) compared with the free combination of linagliptin and metformin extended release tablets in healthy subjects (an open-label, randomised, single dose, two-way crossover trial)

    Study Document Trial synopsis 1288.10_DR english
  • LAXOBERAL ® - Healthy
    Clinical Study Number 122.57
    Study Indication Healthy
    Product LAXOBERAL ®
    Generic Name Bisacodyl
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the pharmacokinetics of 10 mg bisacodyl (coated tablets) or 10 mg sodium picosulfate (drops) administered orally in healthy lactating females.

    Study Document Trial synopsis 122.57_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.511
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, single-dose, two-way cross-over study to assess the bioequivalence of Lendormin® Tablets 0.25 mg (Delpharm Reims) vs. Lendormin® Tablets 0.25 mg (Synmosa Biopharma Co. Ltd.) administered to healthy adult volunteers 

    Study Document Trial synopsis 263.511_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.506
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    Clinical Pharmacological study on absorption from mucous membrane of oral cavity of WE 941 OD tablets

    Study Document Trial synopsis 263.506_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.507
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    The bioequivalence between WE 941 OD tablets (0.25 mg as the basis) taken without water and brotizolam conventional tablets (Lendormin® tablets, 0.2Smg as the basis taken with water, as a single administration in healthy adult male subjects (open-labelled, 2-way cross-over study)

    Study Document Trial synopsis 263.507_CO english
  • LENDORMIN ® - Healthy
    Clinical Study Number 263.508
    Study Indication Healthy
    Product LENDORMIN ®
    Generic Name Brotizolam
    Lab Code
    Clinical Phase I
    Study Title

    The bioequivalence between WE 941 OD tablets (0.25mg as the basis) and brotizolam conventional tablets (Lendormin® tablets, 0.25 mg as the basis), both taken with water as a single administration in healthy adult male subjects (open-labelled, 2-way cross-over study)

    Study Document Trial synopsis 263.508_CO english
  • Lefradafiban - Healthy
    Clinical Study Number 509.118
    Study Indication Healthy
    Product Lefradafiban
    Generic Name Lefradafiban
    Lab Code
    Clinical Phase I
    Study Title

    Influence of 40 mg Pantoprazole per day on the pharmacokinetics of Fradafiban after multiple oral doses of 30 mg Lefradafiban tid as acid free tablet and sachet over 5 days in healthy subjects. A 4-way crossover randomized open trial.

    Study Document Trial synopsis 509.118 english
  • Lefradafiban - Healthy
    Clinical Study Number 509.119
    Study Indication Healthy
    Product Lefradafiban
    Generic Name Lefradafiban
    Lab Code
    Clinical Phase I
    Study Title

    Influence of 40 mg Pantoprazole per day on the pharmacokinetics of Fradafiban after multiple oral doses of 30 mg Lefradafiban tid as acid free tablet and sachet over 5 days in healthy subjects. A 4-way crossover randomized open trial.

    Study Document Trial synopsis 509.119 english
  • Lefradafiban - Healthy
    Clinical Study Number 509.302
    Study Indication Healthy
    Product Lefradafiban
    Generic Name Lefradafiban
    Lab Code
    Clinical Phase I
    Study Title

    Influence of oral doses of 75 mg Clopidogrel on the pharmacodynamics and safety of Fradafiban after oral doses of 30 mg Lefradafiban tid over 8 days in healthy male subjects. An intra-individual, open trial.

    Study Document Trial synopsis 509.302_CO english
  • Linagliptin + Pioglitazone - Healthy
    Clinical Study Number 1264.1
    Study Indication Healthy
    Product Linagliptin + Pioglitazone
    Generic Name Linagliptin + Pioglitazone
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of two fixed dose combination tablets of linagliptin 5 mg/pioglitazone 45 mg compared with single linagliptin 5 mg and pioglitazone 45 mg tablets administered together to healthy male and female subjects (open, randomised, single dose, threeperiod crossover phase I trial)

    Study Document Trial synopsis 1264.1 english
  • Linagliptin + Pioglitazone - Healthy
    Clinical Study Number 1264.14
    Study Indication Healthy
    Product Linagliptin + Pioglitazone
    Generic Name Linagliptin + Pioglitazone
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of a fixed dose combination tablet of linagliptin 5 mg / pioglitazone 30 mg compared with its mono-components in healthy male and female subjects (an open-label, randomised, single-dose, replicate design study with two treatments in four crossover periods)

    Study Document Trial synopsis 1264.14_DR english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.136
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 80 mg telmisartan/12.5 mg HCTZ fixed dose combination compared with its monocomponents in healthy subjects. A 4 period cross-over, randomized, replicate design study.

    Study Document Trial synopsis 502.136 english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.341
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of single oral doses of 40 mg simvastatin and its metabolite simvastatin acid with and without concomitant administration of telmisartan 80 mg daily, given orally over 6 days. A randomised, placebo controlled, double blind (for telmisartan), two way cross over trial in healthy subjects

    Study Document Trial synopsis 502.341_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.378
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind, randomised, placebo controlled, 6 parallel groups study to assess the influence of telmisartan (40 mg or 160 mg), lacidipine (4 mg or 6 mg) and their combination (telmisartan 40 mg and lacidipine 4 mg) p.o. once daily for seven days on the QT interval of the ECG in healthy male and female volunteers

    Study Document Trial synopsis 502.378_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.402
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Does telmisartan compared to candesartan due to a distinctly larger volume of distribution exert stronger effects in relevant peripheral tissues, e.g. renal and adrenal tissues 

    Study Document Trial synopsis 502.402_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.414
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of BIBR 277 tablet (Erythritol based) compared with its capsule formulation in healthy male volunteers.

    Study Document Trial synopsis 502.414_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.417
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of BIBR 277 tablet (Mannitol based) compared with its capsule formulation in healthy male volunteers

    Study Document Trial synopsis 502.417_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.457
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan and SR26334, the main metabolite of clopidogrel, after co-administration compared to the bioavailability of telmisartan and SR26334 after p.o. administration of 80 mg telmisartan and 75 mg clopidogrel alone. A four-way, single dose, open, randomised crossover study in 24 healthy male and female subjects

    Study Document Trial synopsis 502.457_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.458
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan in Micardis® and of dipyridamole in Aggrenox®  after co-administration compared to the bioavailability of telmisartan respectively of dipyridamole after oraladministration of 80 mg telmisartan respectively of 25 mg ASA/200 mg extended-release dipyridamole alone. An open-label,randomised, single-dose, four-way crossover study in 24 healthy female and male subjects

    Study Document Trial synopsis 502.458_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.557
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of the telmisartan 80 mg film-coated tablet compared with two tablets of the telmisartan 40 mg conventional tablet following oral administration in healthy male volunteers (an open-label, randomised, single dose,two-sequence, four-period replicated crossover study)

    Study Document Trial synopsis 502.557_CO english
  • MICARDIS ® - Healthy
    Clinical Study Number 502.520
    Study Indication Healthy
    Product MICARDIS ®
    Generic Name Telmisartan
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of the 40 mg telmisartan film-coated tablet compared with the conventional 40 mg telmisartan tablet following oral administration in healthy male volunteers (an open-label, randomised, single-dose, two-sequence, four period replicated crossover study)

    Study Document Trial synopsis 502.520_CO english
  • MICARDIS ® , MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.324
    Study Indication Healthy
    Product MICARDIS ® ; MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of 40 mg Telmisartan I 12.5 mg HCTZ fixed dose combination compared with its monocomponents in healthy subjects. A 4 period cross-over, open, randomized, replicate design study.

    Study Document Trial synoposis 502.324 english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.415
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan and HCTZ p.o. (80 mg telmisartan/12.5 mg HCTZ) in two experimental formulations (givent.i.d. for one day each) compared to the standard formulation 80 mg telmisartan/12.5 mg HCTZ (MicardisPlus®), given t.i.d. for one day in healthy female and male subjects. A three-way crossover, open,randomised study.

    Study Document Trial synopsis 502.415 english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.437
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 40 mg telmisartan / 12.5 mg HCTZ of fixed dose combination compared to its monocomponents in healthy male volunteers (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 502.437_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.438
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 80 mg telmisartan/12.5 mg HCTZ of fixed dose combination compared to its monocomponents in healthy male volunteers (an open-label, randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 502.438_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.453
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single rising oral doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and multiple oral doses (80 mg Telmisartan / 12.5 mg HCTZ) of drug in healthy male volunteers

    Study Document Trial synopsis 502.453_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.495
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 80 mg telmisartan/12.5 mg HCTZ fixed dosecombination compared with its monocomponents in healthy malevolunteers II (an open-label, randomised, single-dose, two-sequence,four-period replicated crossover study)

    Study Document Trial synopsis 502.495_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.571
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan administrated in two different ways: either in telmisartan 80 mg/HCTZ 12.5 mg fixed-dose combination tablet or as two telmisartan 40 mg tablets (an open-label, randomised, single-dose, four-periodreplicated crossover study)

    Study Document Trial synopsis 502.571_CO english
  • MICARDIS PLUS ® - Healthy
    Clinical Study Number 502.569
    Study Indication Healthy
    Product MICARDIS PLUS ®
    Generic Name Telmisartan + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Influence of food on the bioavailability of telmisartan 40 mg/HCTZ 12.5 mgfixed-dose combination and of telmisartan 80 mg/HCTZ 12.5 mg fixed-dosecombination in Japanese healthy male volunteers (an open-label, randomised,single-dose, two-way crossover study)

    Study Document Trial synopsis 502.569_CO english
  • MICATRIO ® - Healthy
    Clinical Study Number 1348.3
    Study Indication Healthy
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet compared to concomitant administration of telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablet and hydrochlorothiazide 12.5 mg tablet in healthy male subjects: an open-label, randomised, single-dose, two-sequence, four-period replicated crossover study

    Study Document Trial synopsis 1348.3 english
  • MICATRIO ® - Healthy
    Clinical Study Number 1348.4
    Study Indication Healthy
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet compared to concomitant administration of telmisartan 80 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet and amlodipine 5 mg capsule in healthy male subjects (an open-label, randomised, single-dose, two-sequence, four-period replicated crossover study), with influence of food on the bioavailability of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet

    Study Document Trial synopsis 1348.4 english
  • MICATRIO ® - Healthy
    Clinical Study Number 1348.5
    Study Indication Healthy
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of multiple oral doses of telmisartan 80 mg/amlodipine 5 mg /hydrochlorothiazide 12.5 mg fixed-dose combination tablet, telmisartan 80 mg/ hydrochlorothiazide 12.5 mg fixed-dose combination tablet and telmisartan 80 mg/ amlodipine 5 mg fixed-dose combination tablet at steady state in healthy male subjects: an open-label, randomised, multiple-dose, three-treatment, three-period, six-sequence crossover study

    Study Document Trial synopsis 1348.5 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.274
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, single-dose, two-way crossover study to assess the bioequivalence of Meloxicam capsules 15 mg (Mobic Capsules 15 mg) versus Meloxicam tablets 15 mg (Mobic Tablets 15 mg) administered to healthy adult volunteers

    Study Document Trial synopsis 107.274_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.260
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of UH-AC 62 XX tablets 10 mg (TF4) compared with the 10 mg capsule formulations following single peroral administration in healthy volunteers

    Study Document Trial synopsis 107.260_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.259
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of UHAC 62 XX 10 mg tablets compared with 10 mg capsules following multiple peroral administration in healthy volunteers (An open-label, randomised, two-way crossover study)

    Study Document Trial synopsis 107.259_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.255
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Effect of steady state meloxicam 15 mg/day on low dose aspirin (100 mg/day) induced inhibition of platelet aggregation and thromboxane synthesis in healthy males and females. An open, randomised, two-way crossover study.

    Study Document Trial synopsis 107.255 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.254
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomised, four-way crossover study in healthy volunteers to evaluate the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and dose-proportionality over a dosage range of 7.5 mg to 22.5 mg.

    Study Document Trial synopsis 107.254 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.252
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence study of UHAC 62 XX 10 mg tablets compared with 10mg capsules following single peroral administration in healthy volunteers (An open-label, randomised, two-way crossover study)

    Study Document Trial synopsis 107.252_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.251
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Preliminary bioequivalence study of UHAC 62 XX tablets compared with a capsule formulation

    Study Document Trial synopsis 107.251_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.243
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomised, four-way crossover study in healthy volunteers to evaluate the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and dose-proportionality over a dosage range of 7.5 mg to 22.5 mg.

    Study Document Trial synopsis 107.243 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.236
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A double-blind, randomized, parallel group trial to compare the effect of three doses of meloxicam (7.5, 15, and 30 mg) with placebo on bleeding time in healthy male volunteers; and with indomethacin 75 mg (open-label) as an active control to assess trial sensitivity

    Study Document Trial synopsis 107.236_CO english
  • MOBIC ® - Healthy
    Clinical Study Number 107.234
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of 7.5 mg Mobic tablet manufactured in China in comparison with 7.5 mg tablet manufactured in Germany after a single oral dose in Chinese healthy volunteers. Open, randomised, two-way cross-over trial.

    Study Document Trial synopsis 107.234 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.226
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    An open, randomized, three-way cross-over study in healthy volunteers to evaluate the relative bioavailability of meloxicam after single p.o. administration of 2x7.5 mg meloxicam tablets compared to 15 mg meloxicam tablet, and dose-proportionality over a dosage range of 7.5 mg and 15 mg.

    Study Document Trial synopsis 107.226 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.224
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Influence of a high fat breakfast on the pharmacokinetics of UH-AC 62 MU (rapid release tablet) given as an oral single dose of 7.5 mg in healthy subjects (two-way cross-over, randomized, open).

    Study Document Trial synopsis 107.224 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.217
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and tolerability of a single 15 mg meloxicam dose injected intramuscularly compared to a single oral 15 mg meloxicam tablet in healthy subjects. A two-way cross-over, randomized, open study.

    Study Document Trial synopsis 107.217 english
  • MOBIC ® - Healthy
    Clinical Study Number 107.214
    Study Indication Healthy
    Product MOBIC ®
    Generic Name Meloxicam
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and tolerability of 2 x 15 mg meloxicam (2x0.3g topical gel) over 7 days compared to 7.5 mg meloxicam tablet (single oral dose) in healthy subjects. A two-way cross-over, randomized, open study.

    Study Document Trial synopsis 107.214 english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.479
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, two-way crossover study in healthy female and male volunteers to evaluate the relative bioavailability of a 20 mg ambroxol hydrochloride lozenge in comparison to 30 mg ambroxol hydrochloride syrup (Mucosolvan®).

    Study Document Trial synopsis 18.479 english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.488
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of ambroxol hydrochloride following oral administration of soft pastilles 15 mg (Test) compared to 15 mg of syrup (15mg/5mL) (Reference I) and compared to 15 mg of syrup (30mg/5mL) (Reference II) in healthy male and female volunteers. An open-label, randomised, single-dose, 3-way crossover study

    Study Document Trial synopsis 18.488 english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.493
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    A double-blind (at each dose level), randomised, placebo controlled phase I study to evaluate safety, tolerability and pharmacokinetics of increasing repeated oral doses of ambroxol lozenges (dosage: 20, 40, 80 mg three times daily) ove r4 days in healthy male volunteers

    Study Document Trial synopsis 18.493_CO english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.494
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of an open label single dose of 20 mg ambroxol administered as a lozenge together with an oral solution of 0.4 mg [14C]-ambroxol in healthy male volunteers

    Study Document Trial synopsis 18.494_CO english
  • MUCOANGIN ® - Healthy
    Clinical Study Number 18.510
    Study Indication Healthy
    Product MUCOANGIN ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    An open-label, randomized, multiple-dose, three-period crossover study in healthy male and female volunteers to characterize pharmacokinetics and assessthe relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg.

    Study Document Trial synopsis 18.510 english
  • Mucosolvan ® - Healthy
    Clinical Study Number 18.509
    Study Indication Healthy
    Product Mucosolvan ®
    Generic Name Ambroxol
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability study between two formulations containing ambroxol hydrochloride, with administration under fasting condition in healthy volunteers of both sexes: soft pastilles test formulation of ambroxol hydrochloride 15 mg, manufactured by Bolder Arzneimittel GmbH & Co. KG and syrup reference formulation of ambroxol hydrochloride 6 mg/mL (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim Brasil Química e Farmaceutica Ltda.

    Study Document Trial synopsis 18.509 english
  • OFEV ® , VARGATEF ® - Healthy
    Clinical Study Number 1199.161
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of nintedanib given alone and in combination with ketoconazole at steady state in healthy male volunteers (an open-label, randomised, two-way cross-over clinical Phase I study)

    Study Document Trial synopsis 1199.161_DS_DR english
  • OFEV ® , VARGATEF ® - Healthy
    Clinical Study Number 1199.162
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of a single oral dose of nintedanib given alone and in combination with multiple oral doses of rifampicin in healthy male volunteers (an open-label, two-period, fixed-sequence clinical Phase I trial)

    Study Document Trial synopsis 1199.162_DS_DR english
  • OFEV ® , VARGATEF ® - Healthy
    Clinical Study Number 1199.17
    Study Indication Healthy
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase Ia
    Study Title

    Safety and pharmacokinetics/bioavailability of a single dose of 150 mg BIBF 1120 administered as soft gelatine capsules with and without food to healthy male volunteers in an open, randomised intra-individual crossover comparison design

    Study Document