Value through Innovation27 July 2016

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Clinical Study Results

  • BIBB 1464 - Healthy
    Clinical Study Number 1178.1
    Study Indication Healthy
    Product BIBB 1464
    Generic Name BIBB 1464
    Lab Code
    Clinical Phase I
    Study Title

    Safety/Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg Or 2 mg Or 6 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

    Study Document
    Trial synopsis 1178.1 english
  • BIBB 1464 - Healthy
    Clinical Study Number 1178.2
    Study Indication Healthy
    Product BIBB 1464
    Generic Name BIBB 1464
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacodynamics, preliminary pharmacokinetics and tolerability after multiple oral doses of 0.25 mg, 0.5 mg and 1 mg o.d. BIBB 1464 (tablet) or pravastatin 20 mg over 2 weeks in hyperlipemic healthy male subjects (parallel group comparison, randomized, placebo controlled, partly double blind [pravastatin open]).

    Study Document
    Trial synopsis 1178.2 english