Bioequivalence study of glipizide tablets in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.11.018
- VernacularTitle:格列吡嗪片在中国健康受试者中的生物等效性研究
- Author:
Fei-Lang ZHENG
1
,
2
;
Lin-Zhong CHENG
;
Hai-Ju LI
;
Lu YANG
;
Ze-Yuan LIU
;
Su-Ling WANG
Author Information
1. 长治医学院附属和平医院药剂科,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
- Keywords:
glipizide tablet;
bioequivalence;
pharmacokinetics;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(11):1628-1632
- CountryChina
- Language:Chinese
-
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.
