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Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

NCT07543276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-24

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2026-04-03
Completion
2026-04-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543276 on ClinicalTrials.gov