Clinical Pharmacology of Miami, LLC.
Miami, Florida, 33172, United States
NCT Number: NCT07487740
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Miami, Florida, 33172, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Oral tablets
Other names: Nalbuphine
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time frame: Up to Day 18
Trevi Therapeutics
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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