Shenzhen City Zhonglian Pharmacy Co. Ltd.

Potassium chloride sustained-release tablets (KLOR-CON, 10mEq (specification: 750mg)) produced by UPSHER-SMITH LABORATORIES INC were used as the reference preparation, and potassium chloride sustained-release tablets (specification: 0.5g) produced by Shenzhen Zhonglian Pharmaceutical Co., Ltd. were used as the test preparation. The bioequivalence of the two preparations under fasting administration conditions was evaluated through a single-center, randomized, open, two-period, double-crossover clinical trial design. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Metformin hydrochloride tablets (0.5 g) produced by Shenzhen Zhonglian Pharmaceutical Co., Ltd. were used as the test preparation (T), and a bioequivalence study was conducted in accordance with the relevant provisions of the bioequivalence study, with metformin hydrochloride tablets (500 mg, Glucophage®) produced by Merck Santé S.A.S. as the reference preparation (R).

Primary objective: After healthy volunteers were given a single dose of the test preparation metformin hydrochloride tablets (specification: 0.25g, produced by Shenzhen Zhonglian Pharmaceutical Co., Ltd.) or the reference preparation metformin hydrochloride tablets (specification: 250mg, trade name: Glycoran®, produced by NIPPON SHINYAKU CO., LTD.) on an empty stomach or after a meal, the concentration of metformin in plasma was determined to investigate the bioequivalence of the two preparations under the conditions of fasting and after a meal. Secondary objective: To evaluate the safety of the test preparation under the conditions of fasting and after a meal.