Trials / Terminated
TerminatedNCT04236453
A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents
A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Janssen Pharmaceutica N.V., Belgium · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI) when administered as an fixed dose combination (FDC) (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide \[D/C/F/TAF\]) compared to the co-administration as the separate commercial formulations (DRV and F/TAF and COBI), under fed conditions, in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC | Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally on Day 1 of treatment periods with Treatment A. |
| DRUG | Darunavir | Participants will receive a single dose of Darunavir orally on Day 1 of treatment periods with Treatment B. |
| DRUG | Emtricitabine/Tenofovir Alafenamide | Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally on Day 1. |
| DRUG | Cobicistat | Participant will receive a single dose of Cobicistat tablet orally on Day 1. |
Timeline
- Start date
- 2020-01-23
- Primary completion
- 2020-04-10
- Completion
- 2020-04-10
- First posted
- 2020-01-22
- Last updated
- 2020-07-07
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04236453. Inclusion in this directory is not an endorsement.