Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Topamax 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...
Topamax Sprinkle is an investigational small molecule being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in bioequivalence trials comparing it to the reference product Topamax Sprinkle Capsules.
Topamax Sprinkle is being studied in healthy volunteers as part of Phase 1 clinical trials. The trials are designed to assess the bioequivalence of the generic formulation compared to the reference product. No specific therapeutic indication has been established for this investigational drug.
Topamax Sprinkle is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's bioequivalence to the reference product.
Topamax Sprinkle is in Phase 1 clinical development. All three completed trials were Phase 1 studies conducted in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
Topamax Sprinkle has three completed Phase 1 trials: NCT00648934 (fed study), NCT00649467 (applesauce study), and NCT00649740 (fasting study). All trials enrolled healthy adults aged 18 years and older in the United States, with a total enrollment of 107 participants.
Topamax Sprinkle is being studied as a generic version of Topamax Sprinkle Capsules. The clinical trials compare the two formulations to assess bioequivalence. Topamax is the brand name for topiramate, and Topamax Sprinkle is a specific capsule formulation of this drug.