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RECRUITING
NCT07487740
PHASE1
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
Sponsor: Trevi Therapeutics
View on ClinicalTrials.gov
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-02-27
Completion Date
2026-04
Last Updated
2026-03-23
Healthy Volunteers
Yes
Conditions
Interventions
DRUG
NAL ER
Oral tablets
Locations (1)
Clinical Pharmacology of Miami, LLC.
Miami, Florida, United States