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Topiramate Sprinkle · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Topiramate Sprinkle Capsules 25 mg |
| 2 | ACTIVE_COMPARATOR | Topamax® Sprinkle Capsules 25 mg |
| Name | Type | Description |
|---|---|---|
| Topiramate Sprinkle Capsules 25 mg | DRUG | 25mg, single dose fed |
| Topamax® Sprinkle Capsules 25 mg | DRUG | 25mg, single dose fed |
| Topamax® Sprinkle Capsule 25 mg | DRUG | 25mg, single dose fasting |
Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...
Topiramate Sprinkle is a small molecule drug developed by Viatris Inc. (ticker VTRS) as Topiramate Sprinkle Capsules 25 mg. It is an investigational product that has been studied in Phase 1 clinical trials in healthy adult volunteers. Its therapeutic indications have not been disclosed.
Topiramate Sprinkle targets the AMPA and kainate glutamate receptor subunits GRIA1, GRIA2, GRIA3, GRIA4, GRIK1, and GRIK5, acting as an antagonist at these targets. This target profile places it in the small molecule class of glutamate receptor antagonists.
Topiramate Sprinkle is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical program for Topiramate Sprinkle Capsules 25 mg.
Topiramate Sprinkle is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. All three of its recorded Phase 1 trials are completed, and none are currently active.
Topiramate Sprinkle has been studied in three completed Phase 1 trials: NCT00649740, a fasting study; NCT00649467, an applesauce study; and NCT00648934, a fed study. Each compared Topiramate Sprinkle Capsules 25 mg with Topamax Sprinkle Capsules 25 mg in healthy adults in the United States, with total enrollment of 107 participants.