中国临床药理学杂志2024，Vol.40Issue(15)：2241-2245,5.DOI:10.13699/j.cnki.1001-6821.2024.15.019
格列齐特缓释片在中国健康受试者中的生物等效性研究
Bioequivalence study of gliclazide sustained-release tablets in Chinese healthy subjects
摘要
Abstract
Objective To investigate the bioequivalence of gliclazide sustained-release tablets in Chinese healthy subjects.Methods The study was designed using a single-center,open,randomized,single-dose,two-cycle,two-sequence administration method;subjects were orally administered the test/reference preparation 30 mg on an fasting or fed conditions,with self-cross-dosing.The concentration of gliclazide in human plasma was determined by liquid chromatography tandem mass spectrometry(LC-MS/MS)method.The main pharmacokinetic parameters of gliclazide(Cmax,AUC0-t and AUC0-∞)were analyzed by non-atrioventricular model of WinNonlin.Result In the fasting study,24 subjects were recruited and 22 completed the study.The main pharmacokinetic parameters of gliclazide sustained-release tablets test preparation and reference preparation in the fasting group were as follows:Cmax were(862.48±294.48)and(902.96±259.09)ng·mL-1;AUC0-t were(2.60 × 104±8 930.46)and(2.50 ×104±7 573.42)h·ng-1·mL-1;AUC0-∞ were(3.00 × 104±1.43 × 104)and(2.68 × 104±7 085.99)h·ng·mL-1.In the fed study,twenty-four subjects were enrolled and 23 completed the study.The main pharmacokinetic parameters of gliclazide sustained-release tablets test preparation and reference preparation in fed group:Cmax were(1 531.74±273.49)and(1 510.87±241.08)ng·mL-1;AUC0-t were(2.78 ×104±9 565.89)and(2.76 ×104±9 821.43)h·ng·mL-1;AUC0-∞ were(3.02 ×104±1.24 ×104)and(3.02 × 104±1.30 × 104)h·ng·mL-1 h·ng·mL-1.The 90％confidence intervals of the geometric mean ratios of Cmax,AUC0-t,AUC0-∞ for the test preparation and reference preparation gliclazide sustained-release tablets were all between 80％and 125％.Conclusion The test and the reference preparation of gliclazide sustained-release tablets are bioequivalent in Chinese healthy subjects.关键词
格列齐特缓释片/健康受试者/生物等效性/药代动力学/液相色谱-串联质谱法Key words
gliclazide sustained-release tablet/healthy subject/bioequivalence/pharmacokinetics/liquid chromatography tandem mass spectrometry分类
医药卫生引用本文复制引用
段舟萍,赵小伟,温金华,黄世博,李蒲,曹端文..格列齐特缓释片在中国健康受试者中的生物等效性研究[J].中国临床药理学杂志,2024,40(15):2241-2245,5.基金项目
江西省科学技术厅基金资助项目(20232BBH80007) （20232BBH80007）
