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Phenytoin · 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...
Phenytoin is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in a Phase 1 program, and the specific therapeutic indication for this program is not publicly disclosed. Phenytoin is a well-known small molecule and the development work referenced here centers on a bioequivalence study in healthy volunteers.
Phenytoin targets the voltage-gated sodium channels SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker of these channels, which are sodium channel proteins involved in electrical signaling in excitable cells. This target class places Phenytoin among sodium channel blocking small molecules.
Phenytoin is developed by Viatris Inc., which trades under the ticker VTRS. The bioequivalence study of Phenytoin suspension was conducted comparing a Pfizer-made suspension against EPAMIN made by McNeil LA LLC, indicating multiple manufacturers have been involved with Phenytoin formulations.
Phenytoin is in Phase 1 development according to the program tracked for Viatris Inc. The single listed trial is a Phase 1 bioequivalence study that has been completed. No FDA approval status for this specific development program is stated here, so it should be regarded as investigational in this context.
Phenytoin has one listed clinical trial, NCT01122953, titled a bioequivalence study of Phenytoin suspension made by Pfizer versus EPAMIN made by McNeil LA LLC in healthy volunteers under fasting conditions. The trial was Phase 1, active-controlled, randomized, completed, enrolled 34 participants, and was conducted in Mexico with adults 18 years and older.
EPAMIN is a brand-name formulation of phenytoin made by McNeil LA LLC, and the Phenytoin suspension in trial NCT01122953 was compared against EPAMIN to assess bioequivalence. Both refer to phenytoin-based products, with EPAMIN serving as the reference comparator in that healthy volunteer study conducted in Mexico.