← Back to Search

Benzodiazepine

Diazepam Buccal Film following a High-Fat Meal for Epilepsy

Phase 1 & 2
Waitlist Available
Research Sponsored by Aquestive Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC 0-inf
AUC 0-t
Cmax

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Diazepam Buccal Film, Then Diastat Rectal GelExperimental Treatment2 Interventions
Participants received a single dose of Diazepam Buccal Film following a moderate-fat meal and then received a single dose of Diastat Rectal Gel following a moderate-fat meal with a 28-day washout between doses.
Group II: Diazepam Buccal Film following a High-Fat MealExperimental Treatment1 Intervention
Participants who volunteered to participate in the second period received a second dose of Diazepam Buccal Film at the same dose and exactly the same manner as the earlier dose with the exception that the dose was administered following ingestion of a high-fat meal.
Group III: Diastat Rectal Gel, Then Diazepam Buccal FilmExperimental Treatment2 Interventions
Participants received a single dose of Diastat Rectal Gel following a moderate-fat meal and then received a single dose of Diazepam Buccal Film following a moderate-fat meal with a 28-day washout between doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diazepam
FDA approved
Diazepam
FDA approved

Find a Location

Who is running the clinical trial?

Aquestive TherapeuticsLead Sponsor
7 Previous Clinical Trials
271 Total Patients Enrolled
3 Trials studying Epilepsy
208 Patients Enrolled for Epilepsy
Gary Slatko, MDStudy ChairAquestive Therapeutics
~5 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top