Value through Innovation27 July 2016

Clinical Study Results

  • BI 44847 - Healthy
    Clinical Study Number 1224.1
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (2.5 mg to 1200 mg) of BI 44847 as powder in the bottle reconstituted with 0.2% natrosol solution administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blinded trial

    Study Document Trial synopsis 1224.1 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.11
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses (50 mg to 800 mg) of BI 44847 as tablet(s) administered to healthy male subjects. A randomised, placebo-controlled (within dose groups) and double-blinded trial.

    Study Document Trial synopsis 1224.11_CO english
  • BI 44847 - Healthy
    Clinical Study Number 1224.2
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Relative oral bioavailability of 400 mg BI 44847 as suspension compared to 400 mg BI 44847 as tablet and the influence of food (standardised high fat breakfast) on the tablet in a single dose, open label, randomised three-way crossover trial and relative oral bioavailability of 40 mg BI 44847 as solution compared to 40 mg BI 44847 as tablet in healthy male volunteers in a single dose, open-label, randomised two-way crossover trial.

    Study Document Trial synopsis 1224.2 english
  • BI 44847 - Healthy
    Clinical Study Number 1224.22
    Study Indication Healthy
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Evaluation of relative bioavailability of BI 44847 in different ethnic groups (subjects of white, Asian, and African origin), and evaluation of effect of diet and a carbose coadministration on bioavailability following oral administration of 200 mg BI 44847 in healthy male volunteers. An open-label, single-dose, parallel-group, phase I study (group 1 with additional crossover aspects)

    Study Document Trial synopsis 1224.22_CO english
  • BI 44847 - Diabetes Mellitus, Type 2
    Clinical Study Number 1224.3
    Study Indication Diabetes Mellitus, Type 2
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of four multiple rising oral doses (50-800 mg b.i.d. or q.d. for 8 days) of BI 44847 as tablet in female and male patients with type 2 diabetes

    Study Document Trial synopsis 1224.3_CO english
  • BI 44847 - Diabetes Mellitus, Type 2
    Clinical Study Number 1224.4
    Study Indication Diabetes Mellitus, Type 2
    Product BI 44847
    Generic Name BI 44847
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of 4 weeks treatment with three selected oral doses of BI 44847 as tablet in female and male patients with type 2 diabetes

    Study Document Trial synopsis 1224.4 english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.