NCT04718805

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

A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 675 mg in the Presence of 150 mg Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat) Compared to the Co-administration of the Separate Agents (Darunavir and Cobicistat) Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Darunavir	Participants will receive a single dose of Darunavir tablets orally as per assigned treatment sequence.
DRUG	Cobicistat	Participant will receive a single dose of Cobicistat tablets orally as per assigned treatment sequence.
DRUG	Darunavir/Cobicistat FDC	Participants will receive a single dose of darunavir and cobicistat FDC tablets orally as per assigned treatment sequence.

Timeline

• Start date: 2021-01-26
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2021-01-22
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study