At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 68 enrolled
Drug / intervention
Nalmefene Hydrochloride +1 moredrug
Likely dose
Nalmefene Hydrochloride 3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Nalmefene Hydrochloride and Nalmefene for Pharmacokinetics. Completed, enrolled 68 participants across 1 site.
Detailed Summary
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetics
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
Enrollment StartFeb 2021
First PostedFeb 2021
Primary CompletionMay 2021
Study CompletionMay 2021
TodayJul 2026
First PostedFeb 18, 2021
Enrollment StartFeb 8, 2021
Primary CompletionMay 17, 2021
Study CompletionMay 24, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.4 years ago
Interventions
Nalmefene Hydrochloridedrug
3mg nasal spray
Nalmefenedrug
1mg intramuscular injection