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

NCT04718805 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-02-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2021-03-01
Completion
2021-03-01
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718805 on ClinicalTrials.gov