Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions

Viatris

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Phenytoin

Drug: Epamin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01122953

A4121009

Details and patient eligibility

About

To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.

Full description

Bioequivalence study in healthy volunteers

Enrollment

34 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 acceptable representative.

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen.