Study on the relative bioavailability and bioequiavailability of Glipizide capsule

Objective To study the relative bioavailability and bioequiavailability of Glipizide capsule. Method A single oral dose (5mg) of test Glipizide capsule and referent Glipizide capsule were given to 20 volunteers in a randomized crossover study. Glipizide concentrations in plasma were determined by LC/MS/MS method. Results Tmax of test Glipizide capsule and referent Glipizide capsule were (2.1±0.5)h and (2.2±1.1)h respectively; Cmax were (298.95±105.66)ng/ml and (281.55±68.84)ng/ml; t1/2 were (4.14±1.33)h and (3.80±1.28)h; AUC0-t were (1565.89±659.41)ng·h/ml and (1580.13±465.43)ng·h/ml; AUC0-∞ were (1649.53±704.58)ng·h/ml and(1644.15±478.92)ng·h/ml. There was no statistically significant difference between the two preparations in AUC values. Conclusion The relative bioavailability of test Glipizide capsule is(98.3±19.3)%, and the results demonstrate that the two preparations were bioequivalent.