Value through Innovation27 July 2016

Clinical Study Results

  • APTIVUS ® - Hepatic Insufficiency
    Clinical Study Number 1182.32
    Study Indication Hepatic Insufficiency
    Product APTIVUS ®
    Generic Name Tipranavir
    Lab Code
    Clinical Phase I
    Study Title

    An open-label study to determine the pharmacokinetics of single-dose and/or steady-state TPV/r 500/200 mg in subjects with mild and moderate hepatic insufficiency 

    Study Document Trial synopsis 1182.32 english
  • Amelubant - Hepatic Insufficiency
    Clinical Study Number 543.26
    Study Indication Hepatic Insufficiency
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase I
    Study Title

    The Pharmacokinetics, Safety and Tolerability of Single Dose BIIL 284 BS in Patients with Hepatic Impairment in Comparison to Healthy Volunteers (An Open Label, Matched Pair, One Center Study)

    Study Document Trial synopsis 543.26 english
  • JARDIANCE ® - Hepatic Insufficiency
    Clinical Study Number 1245.13
    Study Indication Hepatic Insufficiency
    Product JARDIANCE ®
    Generic Name Empagliflozin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of BI 10773 50 mg single dose in male and female subjects with different degrees of liver impairment (Child-Pugh classification A, B and C) as compared to male and female healthy subjects (a non-blinded, parallel group study of phase I)

    Study Document Trial synopsis 1245.13 english
  • OFEV ® , VARGATEF ® - Hepatic Insufficiency
    Clinical Study Number 1199.200
    Study Indication Hepatic Insufficiency
    Product OFEV ® ; VARGATEF ®
    Generic Name Nintedanib
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety and tolerability of nintedanib single oral dose in male and female patients with different degrees of hepatic impairment (Child-Pugh classification A and B) as compared with nintedanib administration to male and female healthy subjects (a non-blinded, parallel group study of Phase I)

    Study Document Trial synopsis 1199.200 english
  • PRADAXA ® - Hepatic Insufficiency
    Clinical Study Number 1160.51
    Study Indication Hepatic Insufficiency
    Product PRADAXA ®
    Generic Name Dabigatran
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, pharmacodynamics, safety and tolerability of 150 mg dabigatran etexilate p.o. in patients with moderate hepatic impairment compared to subjects with normal hepatic function in a monocentric, open, parallel-group design

    Study Document Trial synopsis 1160.51_CO english
  • TRADJENTA ® - Hepatic Insufficiency
    Clinical Study Number 1218.27
    Study Indication Hepatic Insufficiency
    Product TRADJENTA ®
    Generic Name Linagliptin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics and pharmacodynamics of BI 1356 5 mg once daily in male and female subjects with different degrees of liver impairment (Child Pugh classification A-C) as compared to male and female healthy subjects (a non-blinded, parallel group study of phase I)

    Study Document Trial synopsis 1218.27_CO english

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