Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Diazepam Buccal Film · 3 trials · 1 indication
AUC calculated from time 0 (dosing) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
AUC calculated from time 0 (dosing) to 2 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Tmax calculated from time 0 (dosing) to 2 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Tmax calculated from dosing (Time 0) to 4 hours post-dose in both Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Maximum observed plasma concentration measured from Time 0 to 2 hours post-dose in Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Maximum observed plasma concentration from Time 0 to 4 hours post-dose in Period A (interictal administration) and Period B (ictal/peri-ictal administration)
Observed time to reach maximum drug concentration (Tmax)
Observed Peak Drug Concentration (Cmax)
Area under the Plasma Concentration -time curve from time zero until the last measured time (AUC0-t)
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 |
|---|---|---|
| Interictal Period | EXPERIMENTAL | Each subject received a single dose of DBF based on the subject's age and weight. |
| Ictal/Peri-ictal Period | EXPERIMENTAL | Each subject received a single dose of DBF based on the subject's age and weight. |
| 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 | Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses. |
| Diazepam Buccal Film 12.5 mg | DRUG | All subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods |
| 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: Potential subjects meeting all of the following criteria may be included in the study: 1. Subjects have a clinical diagnosis of epilepsy (GTC seizures or focal seizures with impaired awareness) and were scheduled for admission to an Epilepsy Monitoring Unit (EMU), General Clini...