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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-06-30

Brief Summary

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

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Detailed Description

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Bioequivalence study in healthy volunteers

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Phenytoin

Group Type EXPERIMENTAL

Phenytoin

Intervention Type DRUG

Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.

Epamin

Group Type ACTIVE_COMPARATOR

Epamin

Intervention Type DRUG

Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC

Interventions

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Phenytoin

Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.

Intervention Type DRUG

Epamin

Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes