Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Diastat · 1 trial · 1 indication
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...
Diastat is a small molecule drug being developed for epilepsy. It is an investigational therapy that has completed a Phase 1 clinical trial. The drug is being studied for its potential use in treating epilepsy, though it is not yet approved and remains in clinical development.
Diastat is being developed by Aquestive Therapeutics, Inc., a company traded on the stock exchange under the ticker symbol AQST. The company is conducting clinical research on this drug for the treatment of epilepsy.
Diastat is in Phase 1 of clinical development. It has completed one Phase 1 trial, which was a controlled, randomized crossover study. The drug is investigational and has not been approved by regulatory authorities.
Diastat has been studied in one clinical trial, identified as NCT03953820. This was a Phase 1 crossover study titled "Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study," which enrolled 31 participants with epilepsy in the United States. The trial has been completed.
Diastat is a rectal gel formulation of diazepam. The completed clinical trial compared Diastat Rectal Gel to a Diazepam Buccal Film (DBF) in a crossover study. While both contain diazepam, they are different formulations and routes of administration.