A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence of Darunavir 800 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg, in the Presence of Cobicistat 150 mg, Administered as Either a Fixed-Dose Combination Tablet or as Separate Agents in Healthy Subjects

Trial Profile

A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence of Darunavir 800 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg, in the Presence of Cobicistat 150 mg, Administered as Either a Fixed-Dose Combination Tablet or as Separate Agents in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2017

At a glance

  • Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Cobicistat; Darunavir; Emtricitabine/tenofovir alafenamide
  • Indications HIV-1 infections
  • Focus Pharmacokinetics
  • Sponsors Janssen Sciences Ireland UC
  • Most Recent Events

    • 21 Jul 2017 According to a Janssen-Cilag media release, results from this trial will be presented at the International AIDS Society (IAS) conference.
    • 21 Jul 2017 According to a Janssen-Cilag media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a Positive Opinion recommending marketing authorisation for SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen (STR). The positive opinion was based on the results of this trial.
    • 07 Mar 2016 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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