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.
Kobylińska
M
M
Department of Pharmacology, Pharmaceutical Research Institute, Warsaw, Poland.
Bukowska-Kiliszek
M
M
Barlińska
M
M
Sobik
B
B
Kobylińska
K
K
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