Value through Innovation27 July 2016

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Clinical Study Results

  • BIBP 5371 - Healthy
    Clinical Study Number 1214.1
    Study Indication Healthy
    Product BIBP 5371
    Generic Name BIBP 5371
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of BIBP 5371 CL followingoral administration to healthy male and female volunteers (dose range:10 – 350 mg). A double-blind (within treatment groups), randomised,placebo-controlled, single rising dose study, including comparisons of50 mg vs. 100 mg tablet and tablet vs. drinking solution, andinvestigation of food effect.

    Study Document
    Trial synopsis 1214.1 english