To investigate the bioequivalence between two compounds (phenytoin and epamin) by a randomized, single dose study under fasting conditions in healthy volunteers.
Bioequivalence study in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
34
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
Time frame: 0-168 h
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.
Time frame: 0-168 h
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.
Time frame: 0-168 h
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.
Time frame: 0-168 h
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