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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00833937 | Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Mar 1, 2002 | Mar 1, 2002 | Aug 19, 2024 | 2 | United States |
| NCT00833521 | Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 38 | — | — | Feb 1, 2002 | Feb 1, 2002 | Aug 21, 2024 | 1 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Zolpidem | EXPERIMENTAL | Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period |
| Ambien® | ACTIVE_COMPARATOR | Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Zolpidem 10 mg tablets | DRUG | 1 x 10 mg |
| AMBIEN® 10 mg tablets | DRUG | 1 x 10 mg |
Inclusion Criteria: * All subjects selected for this study will be 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, drug addiction, or serious gastrointe...