drugset
drugset / Trial / NCT04236453

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

NCT04236453 ↗

Phase 1 Terminated 16 enrolled Janssen Pharmaceutica N.V., Belgium
RandomizedCrossoverOpen-labelOther

Summary

The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI) when administered as an fixed dose combination (FDC) (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide \[D/C/F/TAF\]) compared to the co-administration as the separate commercial formulations (DRV and F/TAF and COBI), under fed conditions, in healthy participants.

Timeline

Start
2020-01-23
Primary completion
2020-04-10
Completion
2020-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 675 mg Oral
Subject emtricitabine Other / unclassified 200 mg Oral
Subject tenofovir alafenamide Small molecule 10 mg Oral
Background Cobicistat Small molecule 150 mg Oral

Indications

No indication recorded.