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A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg When Administered as a Fixed Dose Combination tablet (Darunavir/Cobicistat ) Compared to the Co administration of the Separate Available Formulations (Darunavir 100 mg/mL Suspension at a Dose of 600 mg and Cobicistat 90 mg tablet), Under Fed Conditions

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Trial Profile

A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg When Administered as a Fixed Dose Combination tablet (Darunavir/Cobicistat ) Compared to the Co administration of the Separate Available Formulations (Darunavir 100 mg/mL Suspension at a Dose of 600 mg and Cobicistat 90 mg tablet), Under Fed Conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Oct 2022

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At a glance

  • Drugs Cobicistat/darunavir (Primary) ; Cobicistat; Darunavir
  • Indications HIV-1 infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 13 Oct 2022 Status changed from recruiting to completed.
  • 30 Aug 2022 Planned End Date changed from 22 Jul 2022 to 5 Sep 2022.
  • 30 Aug 2022 Planned primary completion date changed from 22 Jul 2022 to 5 Sep 2022.

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