Value through Innovation27 July 2016

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Clinical Study Results

  • Sabiporide - Healthy
    Clinical Study Number 1180.1
    Study Indication Healthy
    Product Sabiporide
    Generic Name Sabiporide
    Lab Code
    Clinical Phase I
    Study Title

    Tolerability and pharmacokinetics of single oral administration of 10,20, 50, 100, 200 and 300 mg BIIB 722 CL (calculated as free base) as drinking solution and of 200, 450, 600 and 750 mg BIIB 722 CL as filmcoated tablet in healthy subjects. An open study with rising doses, partly uncontrolled intra-individual comparison, placebo randomised double blind at each dose level.

    Study Document
    Trial synopsis 1180.1 english
  • Sabiporide - Healthy
    Clinical Study Number 1180.2
    Study Indication Healthy
    Product Sabiporide
    Generic Name Sabiporide
    Lab Code
    Clinical Phase I
    Study Title

    Safety, pharmacodynamics, and pharmacokinetics after multiple oral doses of 200 and 300 mg BIIB 722 CL tablet tid and 300 and 450 mg BIIB 722 CL tablet bid over 7 days to healthy volunteer subjects.  An open study, placebo-controlled randomised double blind at each dose level.

    Study Document
    Trial synopsis 1180.2 english
  • Sabiporide - Healthy
    Clinical Study Number 1180.3
    Study Indication Healthy
    Product Sabiporide
    Generic Name Sabiporide
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and preliminary pharmacokinetics of single rising doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg,50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (calculated as 'free base') and HPBCD given as intravenous infusion over 30 minutes to young healthy male subjects. A single-centre, single-blind, placebo­ controlled, randomised study.

    Study Document
    Trial synopsis 1180.3 english