Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Topamax · 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...
Topamax is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics under various conditions. Topamax is being developed by Teva Pharmaceutical Industries Limited.
Topamax is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development, with all completed trials conducted in healthy volunteers.
Topamax is in Phase 1 clinical development. All four clinical trials associated with the drug have been completed, with a total enrollment of 96 healthy volunteers. The trials were conducted in Canada and involved participants aged 18 years and older.
Topamax has been studied in four completed Phase 1 clinical trials: NCT00904943, NCT00905164, NCT00905346, and NCT00905606. These trials evaluated topiramate 25 mg capsules and tablets under fed and fasting conditions, including mixing with applesauce, in healthy volunteers.
Topamax is the brand name for topiramate, a small molecule drug. The clinical trials for Topamax specifically study topiramate 25 mg formulations, including capsules and tablets, under various administration conditions in healthy volunteers.