Bioequivalence of metformin hydrochloride sustained-release tablets in healthy subjects
10.12092/j.issn.1009-2501.2021.04.008
- Author:
Xiaomin LI
1
;
Wenzhi ZHOU
1
;
Ting ZOU
1
;
Jie GUO
1
;
Pingsheng XU
1
;
Hao JIN
2
;
Hanyue YANG
2
Author Information
1. Phase I Clinical Research Unit, Xiangya Hospital, Central South University
2. Jiangsu Deyuan Pharmaceutical Co., Ltd
- Publication Type:Journal Article
- Keywords:
Bioequivalence;
Metformin hydrochloride sustained-release tablets;
Pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(4):408-413
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To study the bioequivalence of two metformin hydrochloride sustained-release tablets in Chinese healthy subjects. METHODS: A randomized, open-label, two-period, crossover study design was adopted in the study. In fasting test 36 and in fed test 23 healthy subjects were given a single oral dose of metformin hydrochloride sustained-release tablet (0.5 g). The concentration of metformin in plasma was measured by HPLC-MS/MS. The pharmacokinetic parameters were calculated by WinNonlin 7.0 program, and statistical analysis were performed by using SAS9.4 statistics software. RESULTS: In the fasting test, the pharmacokinetic parameters of metformin of the test (T) and reference(R) preparation were as follow: C
