Pilot BA Study With Phase III/Commercial Versus Phase IIB Formulation. A Phase I, Open Label, Randomized, Single Dose, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule.

Trial Profile

Pilot BA Study With Phase III/Commercial Versus Phase IIB Formulation. A Phase I, Open Label, Randomized, Single Dose, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of Potential Phase III Formulations Compared to the Phase IIb Capsule.

Completed
Phase of Trial: Phase I

Latest Information Update: 08 Apr 2013

At a glance

  • Drugs Simeprevir (Primary)
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Most Recent Events

    • 19 Mar 2012 Actual initiation date changed from Jul 2010 to Jun 2010 as reported by ClinicalTrials.gov.
    • 16 Sep 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 08 Jul 2010 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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