A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations

Trial Profile

A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jun 2011

At a glance

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

    • 16 Jun 2011 Actual end date added Jun 2011 as reported by ClinicalTrials.gov.
    • 16 Jun 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 01 Apr 2011 Actual initiation date (Mar 2011) added and additional location identified (Belgium) as reported by ClinicalTrials.gov.
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