31
Participants
Start Date
April 13, 2019
Primary Completion Date
July 31, 2019
Study Completion Date
July 31, 2019
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.
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.
Florida Premier Research Institute, LLC, Winter Park
Bioclinica Research, Orlando
Clinical Trials of Florida, LLC, Miami
Lead Sponsor
Aquestive Therapeutics
INDUSTRY