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drugset / Trial / NCT04718805

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions

NCT04718805 ↗

Phase 1 Completed 22 enrolled Janssen Research & Development, LLC
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to evaluate the single-dose Pharmacokinetic (PK) and bioequivalence of darunavir (DRV) in the presence of cobicistat (COBI) when administered as a scored fixed dose combination (FDC) tablet (DRV/COBI) compared to the co-administration as the separate available tablet formulations (DRV and COBI), under fed conditions in healthy participants.

Timeline

Start
2021-01-26
Primary completion
2021-03-01
Completion
2021-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobicistat Small molecule 150 mg Oral
Subject Darunavir Small molecule 675 mg Oral

Indications

No indication recorded.