Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

April 13, 2019

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Epilepsy
Interventions
DRUG

Diazepam Buccal Film

Diazepam Buccal Film administered on inner aspect of the cheek at the recommended dose regimen (10 mg to 17.5 mg according to body weight) following ingestion of a moderate fat meal and following ingestion of a high-fat meal.

DRUG

Diastat® Rectal Gel (Valeant Pharmaceuticals USA)

Diastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal.

Trial Locations (3)

32789

Florida Premier Research Institute, LLC, Winter Park

32806

Bioclinica Research, Orlando

33186

Clinical Trials of Florida, LLC, Miami

Sponsors
All Listed Sponsors
lead

Aquestive Therapeutics

INDUSTRY