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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00905567 | Topiramate 25 mg Tablets Under Fed Conditions | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2001 | Jun 1, 2001 | Sep 23, 2009 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Test First | EXPERIMENTAL | Topiramate 2 x 25 mg Tablet |
| Reference First | ACTIVE_COMPARATOR | Topamax® Tablet 2 x 25 mg |
| Name | Type | Description |
|---|---|---|
| Topiramate 2 x 25 mg tablet | DRUG | - |
| Topamax® Tablet 2 x 25 mg | DRUG | - |
Inclusion Criteria: * Subjects will be females and/or males, non-smokers, 18 years of age or older * Subjects should read, sign and date an Informed Consent Form prior to any study procedures. * Female subjects will be post-menopausal or surgically sterilized. * Post menopausal status is defined as...