Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Topamax 2 x · 1 trial · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Test First | EXPERIMENTAL | Topiramate 2 x 25 mg Tablet |
| Reference First | ACTIVE_COMPARATOR | Topamax® Tablet 2 x 25 mg |
| Name | Type | Description |
|---|---|---|
| Topiramate 2 x 25 mg tablet | DRUG | - |
| Topamax® Tablet 2 x 25 mg | 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 2 x is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and its therapeutic area is classified as Other.
Topamax 2 x is being studied for use in healthy volunteers. It is currently in Phase 1 clinical trials, which are typically early-stage studies to evaluate the drug's safety, tolerability, and pharmacokinetics in humans. The drug's therapeutic area is classified as Other.
Topamax 2 x 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 one completed trial in healthy volunteers.
Topamax 2 x is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an active-controlled study in healthy volunteers. The drug is still in the early stages of clinical testing and is not yet approved for any indication.
Topamax 2 x has one completed clinical trial registered under NCT00905567, titled 'Topiramate 25 mg Tablets Under Fed Conditions.' This Phase 1 study enrolled 24 healthy volunteers in Canada and was active-controlled, meaning participants received a comparator treatment.
Topamax 2 x is a drug product containing topiramate, as indicated by the clinical trial title 'Topiramate 25 mg Tablets Under Fed Conditions.' The trial studied the drug under fed conditions in healthy volunteers, and it is being developed by Teva Pharmaceutical Industries Limited.