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Label indication TOPAMAX is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine… FDA label
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...
Topiramate is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the work sits within a broader therapeutic area classified as other.
Topiramate targets the AMPA and kainate glutamate receptor subunits GRIA1, GRIA2, GRIA3, GRIA4, GRIK1, and GRIK5. It acts as an antagonist at these targets, meaning it blocks receptor activity. This target profile places topiramate among small molecule drugs that modulate glutamate receptor signaling.
Topiramate is developed by Teva Pharmaceutical Industries Limited, a company listed under the ticker TEVA. Teva is the sponsor associated with the clinical development program for this asset.
Topiramate is in Phase 1 clinical development. It is an investigational small molecule and is not described as approved. Four Phase 1 trials have been completed, and no trials are currently active.
Four completed Phase 1 trials have evaluated topiramate: NCT00905606 tested 25 mg tablets under fasting conditions, NCT00905346 tested 25 mg capsules mixed with applesauce under fasting conditions, NCT00905164 tested 25 mg capsules under fasting conditions, and NCT00904943 tested 25 mg capsules under fed conditions. All enrolled healthy volunteers in Canada.
Yes. Topiramate is also known as topiramate tablets and topiramate capsules, including the 25 mg strength and topiramate 25 mg capsules. These names refer to the same active drug and the same 25 mg formulations studied in the Phase 1 trials.