Value through Innovation27 July 2016

Clinical Study Results

  • Ciluprevir - Healthy
    Clinical Study Number 605.1
    Study Indication Healthy
    Product Ciluprevir
    Generic Name Ciluprevir
    Lab Code
    Clinical Phase I
    Study Title

    Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg,1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400:ethanol solution) in Healthy Male Subjects, Combined with Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two­ Stage Trial Design with Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part).

    Study Document Trial synopsis 605.1 english
  • Ciluprevir - Hepatitis C, Chronic
    Clinical Study Number 605.5
    Study Indication Hepatitis C, Chronic
    Product Ciluprevir
    Generic Name Ciluprevir
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo controlled trial with 25 mg,200 mg and 500 mg BILN 2061 ZW given p.o.at two consecutive days bid to investigate the antiviral efficacy, pharmacokinetics, safety in patients with chronic hepatitis C virus infection

    Study Document Trial synopsis 605.5_CO english
  • Ciluprevir - Hepatitis C, Chronic
    Clinical Study Number 605.9
    Study Indication Hepatitis C, Chronic
    Product Ciluprevir
    Generic Name Ciluprevir
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomised, double-blind, placebo controlled trial with 200 mg BILN2061 ZW given p.o. at two consecutive days bid to investigate the antiviral efficacy, pharmacokinetics, safety in patients with cirrhosis and chronic hepatitis C

    Study Document Trial synopsis 605.9_CO english

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

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