A Phase 1, Open-label, Randomized, 2-panel, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Simeprevir Following Single Dose Administration of Age-appropriate Oral Formulation Candidates, Compared to the 150-mg Oral Capsule, and to Assess the Effect of Food on the Bioavailability of Simeprevir Following Single Dose Administration of a Selected Age-appropriate Oral Formulation Candidate

Trial Profile

A Phase 1, Open-label, Randomized, 2-panel, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Simeprevir Following Single Dose Administration of Age-appropriate Oral Formulation Candidates, Compared to the 150-mg Oral Capsule, and to Assess the Effect of Food on the Bioavailability of Simeprevir Following Single Dose Administration of a Selected Age-appropriate Oral Formulation Candidate

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Sep 2017

At a glance

  • Drugs Simeprevir (Primary)
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 22 Sep 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 26 May 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov record.
    • 14 Mar 2015 New trial record
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