Study to See How Food Affects the Absorption of Nalbuphine Extended-Release Tablets in Healthy Adults Aged 18 to 60

What this Trial Is About

Researchers are studying how a high-fat, high-calorie meal affects the way the body absorbs Nalbuphine Extended-Release Tablets NAL ER after a single oral dose in healthy adults. This phase 1 study aims to understand the relative bioavailability of NAL ER under different dietary conditions. The research is sponsored by Trevi Therapeutics and involves healthy volunteers aged 18 to 60 years with normal body weight and medical health. Participants receive two different doses of NAL ER in a crossover design. They take one dose while fasting and another dose after eating a high-fat, high-calorie meal, with a 3-day break between doses. The study includes two sequences where the order of fasting and fed dosing is reversed, allowing comparison of how food impacts drug absorption. During the study, participants are monitored from Day 1 to Day 8 with blood samples taken at multiple times to measure drug levels, including peak concentration and how long the drug stays in the body. Safety is assessed by tracking any treatment-related side effects up to Day 18. This helps researchers understand the drugs behavior and tolerability under different conditions, with the total participation lasting several weeks.

A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants