Value through Innovation27 July 2016

Clinical Study Results

  • 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 44370 - Migraine Disorders
    Clinical Study Number 1246.4
    Study Indication Migraine Disorders
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) administered orally once during an acute migraine attack of moderate or severe intensity

    Study Document Trial synopsis 1246.4 english
  • BI 44370 - Migraine Disorders
    Clinical Study Number 1246.21
    Study Indication Migraine Disorders
    Product BI 44370
    Generic Name BI 44370
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability following single oral administration of 200 mg of BI 44370 during and between migraine attacks in male and female migraine patients. An open-label, fixed-sequence, two-period study with intraindividual comparison

    Study Document Trial synopsis 1246.21 english

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