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Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

NCT03129347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-03-26

No results posted yet for this study

Summary

This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Conditions

  • Opioid-Related Disorders

Interventions

DRUG

Nalmefene

Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Debra Kelsh, MD · Vince & Associates Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2017-06-09
Completion
2017-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03129347 on ClinicalTrials.gov