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Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 4 mg, 16 mg, 48 mg, 120 mg, 240 mg, 480 mg, 800 mg, and 1200 mg BI 201335 NA (PEG 400/TRIS/Meglumine/Water Solution) in Healthy Male Subjects, in a Randomised Single Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Two-stage Crossover Pilot Bioavailability Comparison of 480 mg BI 201335 NA in a PEG 400/TRIS/Meglumine/Water Solution Coadministered With Food.

Trial Profile

Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 4 mg, 16 mg, 48 mg, 120 mg, 240 mg, 480 mg, 800 mg, and 1200 mg BI 201335 NA (PEG 400/TRIS/Meglumine/Water Solution) in Healthy Male Subjects, in a Randomised Single Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Two-stage Crossover Pilot Bioavailability Comparison of 480 mg BI 201335 NA in a PEG 400/TRIS/Meglumine/Water Solution Coadministered With Food.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Aug 2014

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At a glance

  • Drugs Faldaprevir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Boehringer Ingelheim Pharma KG; Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 14 Apr 2014 New trial record
    • 22 Mar 2014 Results presented at the 115th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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