drugset / Trial / 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
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2022-06-07
- Primary completion
- 2022-09-28
- Completion
- 2022-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cobicistat | Small molecule | 90 mg | Oral |
| Subject | Darunavir | Small molecule | 600 mg | Oral |
Indications
No indication recorded.