中国临床药理学杂志2024，Vol.40Issue(11)：1628-1632,5.DOI:10.13699/j.cnki.1001-6821.2024.11.018
格列吡嗪片在中国健康受试者中的生物等效性研究
Bioequivalence study of glipizide tablets in Chinese healthy subjects
郑飞浪 1程林忠 2李海菊 2杨璐 2刘泽源 3王素玲2
作者信息
- 1. 长治医学院附属和平医院药剂科,山西长治 046000||长治医学院附属和平医院药物临床试验机构,山西长治 046000
- 2. 长治医学院附属和平医院药物临床试验机构,山西长治 046000
- 3. 长治医学院附属和平医院药物临床试验机构,山西长治 046000||中国人民解放军总医院第五医学中心药物临床试验机构,北京 100039
- 折叠
摘要
Abstract
Objective To study the bioequivalence of two glipizide tablets in healthy Chinese subjects.Methods Randomized,open,single-administration,two-period,self-cross-over trial design was used in the study.There were 28 Chinese healthy subjects in the fasted state and 28 in the fed state,complete repeat cross single dose oral glipizide tablets test preparation or reference preparation 5 mg.The plasma concentration of glipizide was determined by liquid chromatography/tandem mass spectrometry at different time points after administration.The non-compartmental model was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence of the two formulations.Results The main pharmacokinetic parameters of glipizide in the fasted state were as follows:Cmax were(551.60±91.26)and(518.10±105.10)ng·mL-1;AUC0-t were(3 074.33±861.91)and(3 026.77±934.25)h·ng·mL-1;AUC0-∞ were(3 204.85±990.78)and(3 166.35±1 107.36)h ng·mL-1.The parameters of glipizide in the fed state were as follows:Cmax were(517.30±98.97)and(472.80±114.48)ng·mL-1;AUC0-t were(3 001.12±830.87)and(2 932.79±736.35)h·ng·mL-1;AUC0-∞ were(3 067.00±918.84)and(2 997.44±819.14)h·ng·mL-1.The 90％confidence interval of the Cmax,AUC0-t and AUC0-∞ of the test formulation and the reference formulation were from 80.00％to 125.00％.The incidence of adverse events in fasted group and fed group was no serious adverse events.Conclusion The two glipizide tablets were bioequivalent under fasted and fed conditions,and good security.关键词
格列吡嗪片/生物等效性/药代动力学/安全性Key words
glipizide tablet/bioequivalence/pharmacokinetics/safety分类
医药卫生引用本文复制引用
郑飞浪,程林忠,李海菊,杨璐,刘泽源,王素玲..格列吡嗪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(11):1628-1632,5.
