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COMPLETED
NCT07543276
PHASE1

Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

Sponsor: Purdue Pharma LP

View on ClinicalTrials.gov

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

DRUG

Nalmefene + 0.94% MgCl2

Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration

DRUG

Nalmefene + 0.94% MgCl2

Nalmefene 0.5 mg + 0.94% MgCl2 for IM administration

DRUG

Nalmefene Hydrochloride Injection

Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration

Locations (1)

Ohio Clinical Trials

Columbus, Ohio, United States