The Relative Bioavailabity of Glipzide Tablets in 20 Healthy Volunteers

OBJECTIVE:A single dose of 10 mg glipizide test tablet or its reference tablet was given to 20 healthy male volunteers in a randomized cross-over study. METHODS: The pharmacokinetics and bioavailability of test glipizide tablets were compared with reference glipizide tablets. Plasma levels of glipizide were detected by HPLC-UV method. RESULTS: It was found that the plasma concentration-time curves of the two preparations were fitted to a one compartment model. The parameters of the two formulations for glipizide: Cmax(μg＠·ml-1) were 622.53 ± 139.96 and 620.95 ± 1 17.36, Tmax (h)1.93 ± 0.18and 1.95 ± 0.15; respectively. MRT(h).5.74 ± 0.37 and 5.96 ± 0.45, AUC0-16(μg· h· L-1): 2848.24 ± 553.24 and 2962.38 ± 530. 13; The relative bioavailability (%) of test tablets was 97. 11 ± 11 .06. CONCLUSION: There were no significant difference between pharmacokinetic parameters for test and reference tablets. It was demonstrated the two preparations were bioequivalent by one two-sided tests.