Bioequivalency study of metformin hydrochloride sustained-release tablets(Ⅲ)in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.23.016
- VernacularTitle:盐酸二甲双胍缓释片(Ⅲ)在中国健康受试者中的生物等效性研究
- Author:
Yi-min SHAO
1
;
Jun YAO
;
Jun LI
;
Bi-kun WANG
;
Wen-zhen XU
;
Ying XU
;
Jun-qing ZHANG
Author Information
1. 北京大学第一医院内分泌科,北京 100034
- Publication Type:Journal Article
- Keywords:
metformin hydrochloride sustained-release tablet(Ⅲ);
bioequivalency;
pharmacokinetics;
health subject
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(23):3444-3448
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the bioequivalency of single administration of metformin hydrochloride sustained-release tablets(Ⅲ)and double administration of metformin hydrochloride tablet by self-cross test in healthy subjects.Methods A two-cycle,open,self-controlled cross-control trial was conducted in which 10 cases healthy subjects first received test prepatration metformin hydrochloride sustained-release tablet(Ⅲ)2.0 g and then received reference preparation(metformin hydrochloride tablet)1.0 g twice daily after a 7-day washout period.The plasma concentrations of metformin at different time points after administration were measured by liquid chromatography tandem mass spectrometry(LC-MS/MS).The pharmacokinetic parameters were calculated by Analyst 1.6.3,and the bioequivalency of the two drugs was evaluated.A double unilateral t-test and 90％confidence interval were used to assess the equivalence.A non-parametric test statistical analysis was used to evaluate the equivalence of the secondary parameter tmax.Results The pharmacokinetic parameters of test prepatration and reference preparation were AUC0-24h were(16.43±4.46)and(18.69±4.68)μg·h·mL-1,AUCINF-obs were(17.60±4.56)and(20.09±5.78)μg·h·mL-1,Cmax were(1 893.97±585.88)and(1 437.35±281.21)ng·mL-1,tmax were(7.60±1.58)and(4.70±2.41)h;t1/2 were(10.95±2.58)and(3.33±0.62)h.Conclusion The peak time and half-life of metformin hydrochloride sustained-release tablet(Ⅲ)after single administration in Chinese healthy subjects are longer than that of metformin hydrochloride tablet,and the bioequivalency is comparable to that of metformin hydrochloride tablet after two administration.
