drugset / Trial / NCT03953820
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2019-04-13
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diazepam | Small molecule | 10 mg | Other |
| Subject | Diazepam | Small molecule | 17.5 mg | Other |
| Subject | Diazepam | Small molecule | 20 mg | Other |