Overview

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

Status:
Completed
Trial end date:
2019-07-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Aquestive Therapeutics
Treatments:
Diazepam