Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epanutin Infatabs · 1 trial · 1 indication
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | Epanutin Infatabs 50 mg (sourced from Germany), 1 x 50 mg (REFERENCE) |
| Treatment B | EXPERIMENTAL | Dilantin Infatabs 50 mg (sourced from Australia), 1 x 50 mg (TEST) |
| Name | Type | Description |
|---|---|---|
| Epanutin Infatabs (Phenytoin) | DRUG | Chewable Tablet, 50 mg, Single dose |
| Dilantin Infatabs (Phenytoin) | DRUG | Chewable Tablet, 50 mg, Single dose |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * An informed consent document signed and dated by the subject. Exclusion Criteria: * Evidence or history of clinically significant abnormalities. * Any condition possibly affecting drug abso...
Epanutin Infatabs is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial assessing its similarity to another formulation. The drug is being developed by Pfizer, Inc. and is not yet approved for any indication.
Epanutin Infatabs is developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company is conducting clinical research on this small molecule drug, which is currently in Phase 1 development for use in healthy volunteers.
Epanutin Infatabs is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently ongoing. The drug remains investigational and has not received FDA approval.
Epanutin Infatabs has one completed clinical trial, NCT01355068, titled 'A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia.' This Phase 1 study enrolled 26 healthy volunteers in Singapore and was active-controlled.
Epanutin Infatabs and Dilantin Infatabs are being compared in a clinical trial to assess if they are similar. The study NCT01355068 evaluated whether Epanutin Infatabs 50 mg from Germany is similar to Dilantin Infatabs 50 mg from Australia, but the results have not been reported.