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.

Eligible Conditions

Epilepsy

Timeline

Screening ~ 3 weeks3 visits

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

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

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