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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00859430 | Levetiracetam 1000 mg Under Non-Fasting Conditions | PHASE1 | COMPLETED | 22 | — | — | Jan 1, 2007 | Jan 1, 2007 | Aug 20, 2024 | 1 | United States |
| NCT00859521 | Levetiracetam 1000 mg Under Fasting Conditions | PHASE1 | COMPLETED | 30 | — | — | Jan 1, 2007 | Jan 1, 2007 | Aug 20, 2024 | 1 | United States |
| NCT00849485 | Levetiracetam 750 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 22 | — | — | Nov 1, 2005 | Nov 1, 2005 | Sep 11, 2009 | 1 | Canada |
| NCT00849862 | Levetiracetam 750 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 22 | — | — | Oct 1, 2005 | Nov 1, 2005 | Sep 11, 2009 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Levetiracetam | EXPERIMENTAL | Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period |
| Keppra® | ACTIVE_COMPARATOR | Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Levetiracetam | DRUG | 1000 mg Tablet |
| Keppra® | DRUG | 1000 mg Tablet |
Inclusion Criteria All subjects must satisfy the following criteria to be considered for study participation: * Subject must be male or non-pregnant, non-breast-feeding female * Subject must be at least 18 years of age * Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive,...