Bioequivalence of glipizide tablets in heathy volunteers

VernacularTitle:格列吡嗪在健康人体的生物等效性
Author: Hai-Yan LI ¹ ; Guang-Tao HAO ; Heng-Yan QU ; Hong-Zhi GAO ; Ze-Yuan LIU ; Yu-Guang LIANG
Author Information

1. 军事医学科学院附属医院临床药理学研究室
Keywords: HPLC-MS/MS; glipizide; bioequivalence
From: The Chinese Journal of Clinical Pharmacology 2014;(6):528-530
CountryChina
Language:Chinese
Abstract: Objective To evaluate the bioequivalent between the two kinds of glipizide tablets.Methods With two-cycle crossover trial was design, 24 healthy male subjects were given a single oral dose 5 mg of glipizide test preparation and reference preparation.Serum samples were collected at different time points before administration and after adminis-tration.The plasma concentrations were measured by HPLC -MS/MS method.The pharmacokinetic parameters and relative bioavailability were calculated by WinNonlin 6.1 software.Results The main pharmacoki-netic parameters of the test and reference glipizide tablets were as fol-lows: tmax were ( 3.40 ±1.54 ) and ( 3.71 ±1.30 ) h, Cmax were (471.88 ±108.10 ) and ( 480.58 ±132.63 ) μg · L-1 , t1/2 were (5.15 ±1.31) and(5.32 ±1.27)h, AUC0-t were (2805.71 ±592.61 ) and (2873.40 ±697.57 )μg· h-1 · L, respectively.F0-t and F0-∞ of test preparation were ( 105.77 ±27.84 )% and ( 105.28 ±27.63 )% re-spectively.Conclusion The glipizide tablets test and reference are bio-equivalent.