Last reviewed 2020-08-18 · How we verify
Home › Trials › NCT03953820 NCT03953820
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
On this page:
Summary Quick facts Who can join Endpoints Results Adverse events Publications Related trials Sources
Completed
Phase 1, PHASE2
Results posted
Last updated 18 August 2020
What this trial tests
Phase 1, PHASE2 trial testing Diazepam Buccal Film in Epilepsy in 31 participants. Completed in 31 July 2019.
Timeline
13 April 2019
Primary endpoint
31 July 2019
Quick facts
Lead sponsor Aquestive Therapeutics Phase Phase 1, PHASE2 Status Completed Study type INTERVENTIONAL Allocation randomized Design crossover Masking none Primary purpose treatment Enrollment 31 Start date 13 April 2019 Primary completion 31 July 2019 Estimated completion 31 July 2019 Sites 3 locations across United States
Drugs / interventions tested
Conditions studied
Sponsor
Aquestive Therapeutics
Who can join
Adults 18 to 65, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
AUC 0-t
Primary
· 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Area Under Plasma Concentration-Time Curve From Time Zero to the last non-zero concentration
Group Value 95% CI DBF Following Moderate-Fat Meal 7290.40 5935.35 – 8954.81 DRG Following a Moderate Fat Meal 5682.09 4625.97 – 6979.31 DBF Following a High Fat Meal 8288.63 6801.31 – 10100.00
AUC 0-inf
Primary
· 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Area under concentration time curve, from time 0 extrapolated to infinity
Group Value 95% CI Diazepam Buccal Film Following a Moderate Fat Meal 8672.09 7553.47 – 9956.32 Diastat Rectal Gel Following a Moderate Fat Meal 6880.96 5993.38 – 7899.98 Diazepam Buccal Film Following a High-Fat Meal 8903.79 7500.99 – 10568.93
Cmax
Primary
· 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Maximum observed plasma concentration
Group Value 95% CI Diazepam Buccal Film Following a Moderate-Fat Meal 204.25 163.41 – 255.32 Diastat Rectal Gel Following a Moderate-Fat Meal 211.22 168.98 – 264.02 Diazepam Buccal Film Following a High-Fat Meal 181.61 138.08 – 240.60
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from the time of signing the Informed Consent until at least 2 weeks following the last study drug administration (50 days overall)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Diazepam Buccal Film Following a Moderate-Fat Meal
Serious: 0/31 (0%)
Deaths: 0/31
Diastat Rectal Gel Following a Moderate-Fat Meal
Serious: 0/29 (0%)
Deaths: 0/29
Diazepam Buccal Film Following a High-Fat Meal
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (6 terms — click to expand) Reaction System Diazepam Buccal Film Follo… Diastat Rectal Gel Followi… Diazepam Buccal Film Follo… Somnolence Nervous system disorders — — — Headache Nervous system disorders — — — Dizziness Nervous system disorders — — — Sedation Nervous system disorders — — — Dysgeusia Nervous system disorders — — — Fatigue General disorders — — —
Data from ClinicalTrials.gov NCT03953820 adverse events section .
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems.
Jacob S, Nair AB, Boddu SHS, Gorain B, et al ·
· 2021
· cited 72×
· PMID 34452167
· DOI 10.3390/pharmaceutics13081206
Pathophysiology to Risk Factor and Therapeutics to Treatment Strategies on Epilepsy.
Boleti APA, Cardoso PHO, Frihling BEF, de Moraes LFRN, et al ·
· 2024
· cited 14×
· PMID 38248286
· DOI 10.3390/brainsci14010071
Verify or expand the search:
Other trials of Diazepam Buccal Film
Trials testing the same drug.
NCT03222349 · Phase 2
· completed
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
NCT07095933 · EARLY_PHASE1
· recruiting
NCT07224191 · NA
· recruiting
NCT07219407 · Phase 2
· recruiting
NCT07417280 · NA
· recruiting
NCT07490769 · Phase 3
· recruiting
Other Aquestive Therapeutics trials
Trials by the same sponsor.
NCT06527937 · Phase 2
· completed
NCT03679975 · Phase 2
· terminated
NCT03457753 · Phase 2
· withdrawn
NCT03428360 · Phase 3
· completed
NCT03222349 · Phase 2
· completed
Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT03953820 (US National Library of Medicine, public domain)Publications : Europe PMC API search by NCT ID, retrieved 10 June 2026Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Aquestive TherapeuticsLast refreshed : 18 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03953820.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing
Not medical advice. Information on this page is collated from primary regulatory and clinical-trial sources for research purposes. It is not a substitute for consultation with a licensed healthcare professional. See our editorial policy for sourcing and methodology.