Value through Innovation27 July 2016

Clinical Study Results

  • 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 - Diabetes Mellitus, Type 2
    Clinical Study Number 1283.2
    Study Indication Diabetes Mellitus, Type 2
    Product BI 135585
    Generic Name BI 135585
    Lab Code
    Clinical Phase Ib
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple-rising oral doses (5 to 100 mg q.d. for 14 days) of BI 135585 XX in patients with type 2 diabetes mellitus (randomised, double-blind, placebo-controlled within dose groups)

    Study Document Trial synopsis 1283.2 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

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