At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Diazepam +1 moredrug
Likely dose
Diazepam 5 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.
A Three-Period, Three-Treatment, Six-Sequence Randomized Crossover Study of the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers",
In Brief
A Phase 1 clinical trial evaluating Diazepam for Epilepsy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
CollaboratorsNeurelis, Inc.
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
Primary CompletionApr 2011
First PostedJun 2011
TodayJul 2026
First PostedJun 2, 2011
Enrollment StartFeb 1, 2011
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.1 years ago
Interventions
Diazepamdrug
Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.
Diazepamdrug
IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.