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

Bioequivalence Study Of 5ml Dose Of PHENYTOIN 125mg/ 5ml Suspension Made By Laboratorios Pfizer, S.A. De C.V. Versus EPAMIN® 125 mg/5ml Made By McNeil LA LLC, Study In Healthy Volunteers Under Fasting Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01122953

Enrollment

Registered

2010-05-13

Start date

2010-04-30

Completion date

2010-06-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioequivalence, EPAMIN, PHENYTOIN

Brief summary

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

Detailed description

Bioequivalence study in healthy volunteers

Interventions

DRUGPhenytoin

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

DRUGEpamin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.	0-168 h
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.	0-168 h
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.	0-168 h

Secondary

Measure	Time frame
Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time.	0-168 h

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026