Trials / Recruiting
RecruitingNCT07487740
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Trevi Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NAL ER | Oral tablets |
Timeline
- Start date
- 2026-02-27
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2026-03-23
- Last updated
- 2026-03-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07487740. Inclusion in this directory is not an endorsement.