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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

Interventions

DRUG

NAL ER

Oral tablets

Locations (1)

Clinical Pharmacology of Miami, LLC.

Miami, Florida, United States