Actively Recruiting
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
Led by Trevi Therapeutics · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) 6 18.0 and 4 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.
You will not qualify if you...
- 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 (Day -1).
- Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
- History of prolonged QT syndrome or a corrected QT (QTc) interval.
- Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.
- Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Pharmacology of Miami, LLC.
Miami, Florida, United States, 33172
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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