[Translation] A randomized, open-label, two-way crossover study to evaluate the bioequivalence of a single 500 mg dose of Glucophage® extended-release tablets (Merck, Jiangsu, China) versus a reduced formulation of Glucophage® extended-release tablets (Merck, Darmstadt, Germany) in healthy subjects in both the fed and fasted states
主要目的:
1.评估在空腹状态下单次口服中国江苏默克制药 生产的格华止®缓释片精简处方(受试制剂) 与德国达姆施塔特默克公司生产的格华止®缓 释片精简处方(参比制剂)后的生物等效性。
2.评估餐后状态下单次口服中国江苏默克制药生产的格华止®缓释片精简处方(受试制剂)与 德国达姆施塔特默克公司生产的格华止®缓释 片精简处方(参比制剂)后的生物等效性。
次要目的:
1. 评估受试制剂和参比制剂单次给药后格华止® 缓释片精简处方的其他 PK 参数。 2. 研究受试制剂和参比制剂单次给药后格华止® 缓释片精简处方的安全性和耐受性。
[Translation] Primary objectives:
1. To evaluate the bioequivalence of a simplified formulation of Glucophage® extended-release tablets produced by Merck Pharmaceuticals, Jiangsu, China (test formulation) and a simplified formulation of Glucophage® extended-release tablets produced by Merck KGaA, Darmstadt, Germany (reference formulation) after a single oral administration in the fasting state.
2. To evaluate the bioequivalence of a simplified formulation of Glucophage® extended-release tablets produced by Merck KGaA, Jiangsu, China (test formulation) and a simplified formulation of Glucophage® extended-release tablets produced by Merck KGaA, Darmstadt, Germany (reference formulation) after a single oral administration in the fed state.
Secondary objectives:
1. To evaluate other PK parameters of the simplified formulation of Glucophage® extended-release tablets after a single administration of the test formulation and the reference formulation. 2. To study the safety and tolerability of the simplified formulation of Glucophage® extended-release tablets after a single administration of the test formulation and the reference formulation.