Value through Innovation27 July 2016

Clinical Study Results

  • 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

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