A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects

Trial Profile

A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jan 2015

At a glance

  • Drugs Cobicistat/darunavir (Primary) ; Cobicistat; Darunavir
  • Indications HIV infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 03 Jul 2013 Primary endpoint 'Time-to-peak-drug-concentration' has been met, according to the 7th International AIDS Society Conference on HIV Pathogenesis and Treatment abstract.
    • 03 Jul 2013 Primary endpoint 'Peak-drug-concentration' has been met, according to the 7th International AIDS Society Conference on HIV Pathogenesis and Treatment abstract.
    • 03 Jul 2013 Primary endpoint 'Area-under-the-drug-concentration-time-curve' has been met, according to the 7th International AIDS Society Conference on HIV Pathogenesis and Treatment abstract.
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