Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.
Bioequivalence
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Single dose of 75 mg (10 ml in suspension) of Epamin
Single dose of 75 mg (10 ml in suspension) of Phenytoin
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
To prove the bioequivalence of Phenytoin versus Epamin by measuring; Area under the curve (AUC), Maximum Concentration (Cmax), Time maximum concentration (tmax), Constant of elimination (ke), Elimination half life (t1/2)
Time frame: April 2010 - May 2010
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