Value through Innovation27 July 2016

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Clinical Study Results

  • BI 660848 - Pain
    Clinical Study Number 1284.1
    Study Indication Pain
    Product BI 660848
    Generic Name BI 660848
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) Phase I study to a) assess safety, tolerability and pharmacokinetics of single rising oral doses 2 mg to 600 mg of BI 660848 administered as oral drinking solution (powder in bottle) in healthy male volunteers, b) to explore the relative oral bioavailability of an immediate release tablet formulation, c) to assess the impact of a high fat meal on the oral bioavailability of the oral drinking solution (powder in bottle) and d) assess safety, tolerability and pharmacokinetics of single rising oral doses of 800 mg and 1000 mg of BI 660848 administered as 100 mg tablets (800 mg = 8 tablets and 1000 mg = 10 tablets) once daily

    Study Document
    Statement 1284.1_DR english
    Trial synopsis 1284.1 english