Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Topiramate Tablets
Topiramate · 4 trials · 1 indication
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...