Trials / Completed
CompletedNCT04553042
A Study of Seltorexant in Healthy Participants
A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence Between Different Formulations and Phase 3 Formulation of Seltorexant Under Fasted Conditions in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 69 (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 bioequivalence of Test 1 and/or Test 2 seltorexant tablet formulations with respect to Reference seltorexant tablet formulation in healthy participants receiving a single dose under fasted conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Seltorexant | Seltorexant will be administered orally as per assigned treatment sequence. |
Timeline
- Start date
- 2020-09-14
- Primary completion
- 2020-12-20
- Completion
- 2020-12-30
- First posted
- 2020-09-17
- Last updated
- 2025-04-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04553042. Inclusion in this directory is not an endorsement.