Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epamin: Reference Drug · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Epamin: McNeil LA LLC | ACTIVE_COMPARATOR | - |
| Phenytoin: Laboratorios Pfizer SA DE CV | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Epamin: Reference Drug | DRUG | Single dose of 75 mg (10 ml in suspension) of Epamin |
| Phenytoin: Study Drug | DRUG | Single dose of 75 mg (10 ml in suspension) of Phenytoin |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive * A Body Mass Index (BMI) of 18 to 26.9 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs) * An informed consent document signed and dated by the subject or ...
Epamin is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in a bioequivalence study to compare a phenytoin suspension with Epamin in healthy adult volunteers.
Epamin is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this drug in healthy volunteer populations.
Epamin is in Phase 1 clinical development. It is an investigational drug that has completed one Phase 1 trial. The drug is not approved and remains in the clinical research stage.
Epamin has one completed clinical trial registered as NCT01122940, titled "Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers." This Phase 1 study enrolled 32 healthy participants in Mexico and evaluated the drug in an active-controlled, randomized design.
Epamin is being studied in comparison with phenytoin suspension in a bioequivalence trial. The study is designed to assess whether Epamin is bioequivalent to phenytoin suspension in healthy volunteers, but the drug's relationship to phenytoin beyond this trial context is not established.