Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Epamin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Phenytoin | EXPERIMENTAL | - |
| Epamin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Phenytoin | DRUG | Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V. |
| Epamin | DRUG | Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years * 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 a legally ac...
Epamin is a small molecule drug being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. Epamin has been studied in healthy volunteers, and its therapeutic area is classified as Other. It is an investigational drug and has not been approved by regulatory authorities.
Epamin has been studied in healthy volunteers, as part of a bioequivalence study. The study was conducted to compare the pharmacokinetics of phenytoin suspension made by Pfizer with Epamin made by McNeil LA LLC under fasting conditions. Epamin is not indicated for any specific disease or condition.
Epamin is being developed by Pfizer, Inc., a company listed on the stock exchange under the ticker PFE. The drug was studied in a trial that compared Pfizer's phenytoin suspension with Epamin manufactured by McNeil LA LLC. Pfizer is the developer of Epamin.
Epamin is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a bioequivalence study in healthy volunteers. The trial is no longer active, and Epamin remains an investigational drug that has not been approved for any use.
Epamin has been studied in one clinical trial, identified as NCT01122953. This was a Phase 1 bioequivalence study conducted in Mexico, comparing Pfizer's phenytoin suspension with Epamin in healthy volunteers under fasting conditions. The trial enrolled 34 participants and has been completed.
Epamin is a brand name for a phenytoin product. In the clinical trial NCT01122953, Epamin made by McNeil LA LLC was compared with a phenytoin suspension made by Pfizer. Phenytoin is the active ingredient, and Epamin is one of its brand names.