NCT03953820

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

Randomized, Open-Label, 2-Way Crossover, 3-Period Study to Evaluate Single Doses of Diazepam Buccal Film Compared With Diazepam Rectal Gel in Adult Males and Females on Concomitant Antiepileptic Drugs for the Treatment of Epilepsy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Aquestive Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This was a multiple centers, single-dose, open-label, randomized two-sequence crossover, two-period study to evaluate the pharmacokinetics (PK) of single doses of Diazepam Buccal Film (DBF) compared with Diastat® Rectal Gel (DRG) under fed conditions in adult male and female participants on a stable concomitant regimen of anti-epileptic drugs for the treatment of epilepsy.

Detailed description

Period 1 was a randomized, 2-sequence, crossover study in which participants received DBF and DRG following a moderate-fat meal in a randomized sequence with a washout period of 28 days between doses. DBF dose was based on body weight according to the currently recommended dose regimen (derived by Aquestive from population PK modeling in healthy volunteers). DRG dose was based on body weight according to the current product labeling for DRG. Period 2: Participants who completed Period 1 were asked to participate in a second period on a voluntary basis during which volunteers received a second dose of DBF administered at the same dose and in exactly the same manner as the earlier dose of DBF with the exception that DBF was administered following a high-fat meal.

Conditions

• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-13
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2019-05-17
• Last updated: 2020-08-18
• Results posted: 2020-08-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study