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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00904943 | Topiramate 25 mg Capsules Under Fed Conditions | PHASE1 | COMPLETED | 18 | — | — | Jun 1, 2002 | Jul 1, 2002 | Sep 19, 2024 | 1 | Canada |
| NCT00905164 | Topiramate 25 mg Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2002 | Jun 1, 2002 | Sep 19, 2024 | 1 | Canada |
| NCT00905346 | Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2002 | Jul 1, 2002 | Aug 20, 2024 | 1 | Canada |
| NCT00905606 | Topiramate 25 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 30 | — | — | Jun 1, 2001 | Jun 1, 2001 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-72
| Arm | Type | Description |
|---|---|---|
| Test First | EXPERIMENTAL | Topiramate Capsules, 25 mg |
| Reference First | ACTIVE_COMPARATOR | Topamax® Capsules, 25 mg |
| 1 | EXPERIMENTAL | Topiramate Tablets, 25 mg |
| 2 | ACTIVE_COMPARATOR | Topamax® Tablets, 25 mg |
| Name | Type | Description |
|---|---|---|
| Topiramate Capsules, 25 mg | DRUG | 2 x 25 mg Capsules |
| Topamax® Capsules, 25 mg | DRUG | 2 x 25 mg Capsules |
| Topiramate 25 mg Capsules | DRUG | Topiramate Capsules 2 x 25 mg |
| Topamax® 25 mg Capsules | DRUG | Topamax® Capsule 2 x 25 mg |
| Applesauce | OTHER | Applesauce |
| Topiramate Tablets | DRUG | - |
| Topamax® Tablets | 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...