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Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens

NCT05219669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-05

Study results available
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Summary

This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and as two doses in one nostrils; and to evaluate the safety and tolerability of nalmefene IN.

Conditions

Interventions

DRUG

Nalmefene Hydrochloride

30 mg/mL solution

Sponsors & Collaborators

  • Opiant Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Ingela Danielsson, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2021-11-19
Completion
2021-11-22
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 NCT05219669 on ClinicalTrials.gov