Value through Innovation27 July 2016

Clinical Study Results

  • 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

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