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A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

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A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Aug 2022

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At a glance

  • Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Cobicistat; Darunavir; Emtricitabine/tenofovir alafenamide
  • Indications HIV-1 infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Janssen Research & Development; Janssen Sciences Ireland UC

    • Most Recent Events

    • 28 Jul 2021 Status changed from recruiting to completed.
    • 03 Jun 2021 Planned number of patients changed from 32 to 37.
    • 03 Jun 2021 Planned End Date changed from 5 May 2021 to 20 Jul 2021.

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