Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03953820 | Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study | PHASE1 | COMPLETED | 31 | — | — | Apr 13, 2019 | Jul 31, 2019 | Aug 18, 2020 | 3 | United States |
Area Under Plasma Concentration-Time Curve From Time Zero to the last non-zero concentration
Area under concentration time curve, from time 0 extrapolated to infinity
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Diazepam Buccal Film, Then Diastat Rectal Gel | EXPERIMENTAL | 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. |
| Diastat Rectal Gel, Then Diazepam Buccal Film | EXPERIMENTAL | 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. |
| Diazepam Buccal Film following a High-Fat Meal | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Diazepam Buccal Film | DRUG | Diazepam Buccal Film administered on inner aspect of the cheek at the recommended dose regimen (10 mg to 17.5 mg according to body weight) following ingestion of a moderate fat meal and following ingestion of a high-fat meal. |
| Diastat® Rectal Gel (Valeant Pharmaceuticals USA) | DRUG | Diastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal. |
Inclusion Criteria: 1. Male or female, smoker (no more than 25 cigarettes or equivalent daily) or non-smoker, ≥ 18 and ≤ 65 years of age, with body weight between 38 and 111 kg, inclusive. Potential subjects with weights in the range of 112 to 134 kg (247 - 249 pounds) may be allowed to participate...