Value through Innovation27 July 2016

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Clinical Study Results

  • BIRT 1696 - Healthy
    Clinical Study Number 1195.1
    Study Indication Healthy
    Product BIRT 1696
    Generic Name BIRT 1696
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacokinetics and pharmacodynamics of single rising oral doses of BIRT 1696 BS as a solution (10, 100, 400, 1000, 2000, 3000 mg) in 15 ml PEG 400 to healthy human subjects. A three part study: part 1 placebo-controlled, randomised, dose escalating double blinded within each dose level; part 2 open label grapefruit juice effect in 100 mg dose level group; part 3 open label food effect in 400 mg dose level group.

    Study Document
    Trial synopsis 1195.1_CO english