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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00829868 | Zaleplon 10 mg Capsules Under Non-Fasting Conditions | PHASE1 | COMPLETED | 42 | — | — | Feb 1, 2004 | Mar 1, 2004 | Aug 21, 2024 | 1 | United States |
| NCT00829998 | Zaleplon 10mg Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 40 | — | — | Feb 1, 2004 | Feb 1, 2004 | Aug 21, 2024 | 1 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Zaleplon | EXPERIMENTAL | Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period |
| Sonata® | ACTIVE_COMPARATOR | Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Zaleplon 10 mg Capsules | DRUG | 1 x 10 mg |
| SONATA® 10 mg capsules | DRUG | 1 x 10 mg |
Inclusion Criteria: * non-smokers * at least 18 years of age * subjects will have a BMI (body mass index) of 30 or less Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption(past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or car...