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: 26 Sep 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

    • 26 Sep 2017 According to a Janssen-Cilag media release, the European Commission has approved the use of Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single-tablet regimen (STR), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg.
    • 26 Jul 2017 Primary endpoint (Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) has been met as per results presented at the 9th International AIDS Society Conference on HIV Science.
    • 26 Jul 2017 Primary endpoint (Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Darunavir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) has been met as per results presented at the 9th International AIDS Society Conference on HIV Science.
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