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Clinical trial

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects 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

NCT04236453 is registered in ClinicalTrials.gov with Janssen Pharmaceutica N.V., Belgium as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects 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
Lead sponsor
Janssen Pharmaceutica N.V., Belgium
Phase
Phase 1
Overall status
Terminated
Start date
January 23, 2020
Completion date
April 10, 2020
Enrollment
16 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy