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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00849797 | Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 120 | — | — | Jul 1, 2005 | Jul 1, 2005 | Aug 19, 2024 | 1 | Canada |
| NCT00850174 | Oxcarbazepine 600 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 60 | — | — | Apr 1, 2005 | May 1, 2005 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Oxcarbazepine | EXPERIMENTAL | Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period |
| Trileptal® | ACTIVE_COMPARATOR | Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Oxcarbazepine | DRUG | 600 mg Tablet |
| Trileptal® | DRUG | 600 mg Tablet |
Inclusion Criteria * Male or female, smoker or non-smoker, 18 years of age and older. * BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2 Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study: * Clinically significant illnesses or s...