Two bioequivalence studies of Pentoxifylline will be carried out in 40 healthy subjects, the first in a fasting condition 40 healthy subjects, the first in fasting condition and the second in postprandial condition. postprandial condition, the two studies follow the same design: Complete crossover design, randomized, comparative of two study formulations, in single dose of 400 mg of Pentoxifylline sustained release tablets, 2 periods, with a washout time of 7 days between doses, the 7 days between doses, participation as a subject in these studies involves a risk studies involves a higher than minimal risk for subjects.
To establish the main pharmacokinetic variables of the two formulations for the active formulations for the active ingredient pentoxifylline and the metabolites metabolites M1 Metabolite I (1- \[5-hydroxyhexyl\] -3,7- \[5-hydroxyhexyl\] -3,7- dimethylxanthine) and dimethylxanthine) and M5 Metabolite V (1- \[3- \[3-carboxypropyl\] -3,7- \[3-carboxypropyl\] -3,7- dimethylxanthine)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
400 mg
400 mg
Pharmacokinetic Outcome Measures
Peak Plasma Concentration (Cmax)
Time frame: 0 to 24 hours
Pharmacokinetic Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Time frame: 0 to 24 hours
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