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Clinical trial

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

NCT05378906 is registered in ClinicalTrials.gov with Janssen Research & Development, LLC as lead sponsor.

NCT NCT05378906
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Overall status
Completed
Start date
June 7, 2022
Completion date
September 28, 2022
Enrollment
32 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy