Completed
PHASE1
INTERVENTIONAL
NCT01122953
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
View on ClinicalTrials.gov
Updated Dec 15, 2025
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
Name:
Phenytoin
Type:
DRUG
Description:
Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.
Name:
Epamin
Type:
DRUG
Description:
Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC
Primary Outcomes
Measure:
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
TimeFrame:
0-168 h
Description:
Measure:
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.
TimeFrame:
0-168 h
Description:
Measure:
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.
TimeFrame:
0-168 h
Description:
Trial Information
NCT ID
NCT01122953
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last Updated
December 15, 2025