Conditions: Epilepsy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief 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

Detailed description:
Diazepam is a medication that is used for the treatment of seizures. It was approved by the Food and Drug Administration (FDA) for use in the United States and is currently sold as Valium® tablets, Diazepam Injection and Diastat® rectal gel.

This study will evaluate two intranasal (nasal spray) formulations of diazepam which will be supplied by Neurelis, Inc. 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. "Bioavailability" is a measure of how much drug is absorbed and present in the blood. "Pharmacokinetics" means to study the way a drug enters and leaves the blood and tissues over time

Arms:
arm 1: Diazepam Nasal Suspension - 10 mg arm 2: Diazepam Nasal Spray Solution - 10 mg arm 3: Diazepam injection IV - 5 mg

Interventions: intervention 1: Diazepam intervention 2: Diazepam
Intervention descriptions: intervention 1: Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose. intervention 2: IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.

Protocol document: