Comparison of pharmacokinetics and bioavailability of two kinds of glipizide tablets in healthy volunteers

AIM: To compare the relative bioavailability and evaluate the bioequivalant of two glipizide tablets in healthy volunteers man (tablet A was made by Farmitalia Carloerba, tablet B was made by Hannan Willine Pharmaceutical LTD. of P.R. China). METHODS: The relative bioavailability test was carried out in eight healthy volunteers(male) by orally administration 10 mg of glipizide tablets (A or B) on random cross method. A reverse phase high pressurre liquid chromatography(HPLC) was used to determinate plasma glipizide. RESULTS: The HPLC method had a linear concentration range from 20-1000 μg·L -1 ( r =0.9995), the recoveries varied from 99.70%-106.34%, and RSD was 3.09%-6.83% within a day, 2.22%-4.13% out of days. The results of a relative bioavailability test between tablet A and B were that C max was (555± s 173)μg·L -1 and (552±86)μg·L -1 respectively, T max (1.1±0.2)h and (1.6±0.3)h, T 12 (4.6± 1.2 )h and (4.2±0.6)h, AUC 0-T (2876±468)μg·h·L -1 and (3104±582)μg·L -1 ·h -1 . C max , T 12 and AUC 0-T of two formulations had not significant differences( P 0.05). T max of two tablets had significant differences( P 0.01). It meant tablet A had a shorter peak trough time than tablet B. CONCLUSION: Two kinds of glipizide tablets were bioequivalent. Graduate (College of Pharmacy, Shanghai Medical University)