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NCT03953820 · ClinicalTrials.gov registry record · Phase 1
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
A Phase 1 study of Epilepsy, sponsored by Aquestive Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 3
- Study locations
NCT03953820: Completed Phase 1 study of Epilepsy, sponsored by Aquestive Therapeutics.
NCT03953820 is a Phase 1 study of Epilepsy that has completed, run by Aquestive Therapeutics. The registered enrollment target is 31 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03953820, a Phase 1 study of Epilepsy, has completed, sponsored by Aquestive Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Area Under Plasma Concentration-Time Curve From Time Zero to the last non-zero concentration
Conditions Studied
Interventions
- DRUG Diazepam Buccal Film
- DRUG Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
Study Locations (3)
Florida
- Clinical Trials of Florida, LLC - Miami
- Bioclinica Research - Orlando
- Florida Premier Research Institute, LLC - Winter Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-04-13 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
What the finished NCT03953820 record still lists
NCT03953820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Diazepam Buccal Film is the first listed.
NCT03953820 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03953820 about?
NCT03953820 is a clinical study titled "Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study". 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...
What is the current status of trial NCT03953820?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2019-04-13. Estimated completion is 2019-07-31.
What conditions does trial NCT03953820 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT03953820?
The interventions under investigation include: Diazepam Buccal Film (DRUG), Diastat® Rectal Gel (Valeant Pharmaceuticals USA) (DRUG).
Who is sponsoring clinical trial NCT03953820?
This trial is sponsored by Aquestive Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03953820 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03953820's enrollment target sits among peer trials
31 107th of 160 higher than 53 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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