Value through Innovation27 July 2016

Clinical Study Results

  • BIBT 986 - Healthy
    Clinical Study Number 1192.1
    Study Indication Healthy
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability and pharmacokinetics/-dynamics of single rising dosesof 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986BS (IV infusion over 30 minutes) in healthy male subjects. Placebo controlled, double blind randomised at each dose level

    Study Document Trial synopsis 1192.1_CO english
  • BIBT 986 - Healthy
    Clinical Study Number 1192.11
    Study Indication Healthy
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the effect of 0.9, 2.25 or 4.5 mg of BIBT 986 over 1 hour, followed by 0.2, 0.5 or 1.0 mg/hours of BIBT 986 for 7 hours given as IV infusion on tissue factor triggered coagulation in a randomised, placebo controlled, dose escalation design in healthy male volunteers

    Study Document Trial synopsis 1192.11_CO english
  • BIBT 986 - Renal Insufficiency
    Clinical Study Number 1192.12
    Study Indication Renal Insufficiency
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Influence of different degrees of renal impairment on the safety,tolerability, pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose infusion over 30 minutes in subjects with normal renal function and patients with different degrees of renal impairment in an open, group-comparison design

    Study Document Trial synopsis 1192.12_CO english
  • BIBT 986 - Healthy
    Clinical Study Number 1192.2
    Study Indication Healthy
    Product BIBT 986
    Generic Name BIBT 986
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability and pharmacokinetics/-dynamics of 0.5 mg and 1.0 mg(actual 0.8 mg) of BIBT 986 BS per hour given as IV infusion over 32 hours in healthy male subjects. Placebo controlled, double blind randomised at each dose level

    Study Document Trial synopsis 1192.2_CO english

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