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

Trevi Therapeutics

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.

Eligibility

Age range: 18–60 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening. * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee. Exclusion Criteria: * Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1). * History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing. * Positive urine drug or alcohol results at Screening or check in (…

Interventions

Drug
NAL ER
Oral tablets

Location

Clinical Pharmacology of Miami, LLC.
Miami, Florida
hcatala@ergclinical.com 305-817-2900

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

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions