A bioequivalence study of two brands of glipizide tablets.
In this open, randomized, two way crossover, bioequivalence study, two 5 mg tablet preparations of glipizide (Glipizyd tabl. 5 mg, Tarchomińskie Zakłady Farmaceutyczne POLFA S.A., and Glibenese tabl. 5 mg, Pfizer), were compared in 24 healthy male volunteers. Pharmacokinetic variables (mean maximum plasma concentration, mean time to reach maximum plasma concentration, and the mean area under the plasma concentration-time curve) were not statistically significantly different for the two formulations. It can be concluded that the two tablet preparations of glipizide are likely to be bioequivalent.
Department of Pharmacology, Pharmaceutical Research Institute, Warsaw, Poland.
M
M
Kobylińska
M
M
Bukowska-Kiliszek
M
M
Barlińska
B
B
Sobik
K
K
Kobylińska
D000328:Adult; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D005913:Glipizide / Q000008:administration & dosage / Q000032:analysis / Q000493:pharmacokinetics*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000032:analysis / Q000493:pharmacokinetics*; D008297:Male; D015203:Reproducibility of Results; D013607:Tablets; D013810:Therapeutic Equivalency
D007004:Hypoglycemic Agents; D013607:Tablets; D005913:Glipizide