Overview

A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants

Status:
Completed

Trial end date:
2016-02-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF 200/10 mg FDC) in the presence of 150 mg Cobicistat (COBI), under fed conditions, in healthy participants.

Phase:

Phase 1

Details

Lead Sponsor:

Janssen Sciences Ireland UC

Treatments:

Cobicistat
Darunavir
Emtricitabine
Emtricitabine tenofovir alafenamide
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir