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Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
Sponsor: Purdue Pharma LP
Summary
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
Official title: A Phase 1, Open Label, Randomized, Single Dose, Three-Period Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Profiles of Nalmefene Following Administration of Intravenous and Intramuscular Nalmefene 0.5 mg (0.94% MgCl2) and Intravenous Nalmefene Hydrochloride Injection 0.5 mg
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2026-02-06
Completion Date
2026-04-03
Last Updated
2026-04-24
Healthy Volunteers
Yes
Conditions
Interventions
Nalmefene + 0.94% MgCl2
Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration
Nalmefene + 0.94% MgCl2
Nalmefene 0.5 mg + 0.94% MgCl2 for IM administration
Nalmefene Hydrochloride Injection
Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration
Locations (1)
Ohio Clinical Trials
Columbus, Ohio, United States