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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Epamin; Drug: Phenytoin

• Registration Number: NCT01122953
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-13
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Epamin	Epamin	-
Phenytoin	Phenytoin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇲🇽 Mexico, Distrito Federal, Mexico