At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Nalmefene Hydrochloridedrug
Likely dose
Nalmefene Hydrochloride 30 mgfrom 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.
An Open-Label, Three-Period, Three-Treatment, Six-Sequence, Randomized Crossover Study of the Pharmacokinetics of Intranasal Nalmefene in Healthy Volunteers Using Three Dosing Regimens
In Brief
A Phase 1 clinical trial evaluating Nalmefene Hydrochloride for Opioid Overdose. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Overdose
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartSep 2021
Primary CompletionNov 2021
Study CompletionNov 2021
First PostedFeb 2022
TodayJul 2026
First PostedFeb 2, 2022
Enrollment StartSep 1, 2021
Primary CompletionNov 19, 2021
Study CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.4 years ago
Interventions
Nalmefene Hydrochloridedrug
30 mg/mL solution