NCT05378906

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants

A Single-dose, Open-label, Randomized, Crossover Pivotal Bioequivalence Study in Healthy Participants to Assess the Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg When Administered as a Fixed Dose Combination Tablet (Darunavir/Cobicistat) Compared to the Co-administration of the Separate Available Formulations (Darunavir 100 mg/mL Suspension at a Dose of 600 mg and Cobicistat 90 mg Tablet), Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (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 DRV/COBI fixed dose combination (FDC) tablet dispersed in water compared to the co-administration of the separate available formulations (DRV suspension and COBI tablet) under fed conditions in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DRV/COBI FDC	Participants will receive a single oral dose of DRV/COBI FDC tablet dispersed in water as per assigned treatment sequence.
DRUG	COBI	Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence.
DRUG	DRV	Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence.

Timeline

• Start date: 2022-06-07
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2022-05-18
• Last updated: 2022-10-26

Locations

1 site across 1 country: Belgium