Shenzhen City Zhonglian Pharmacy Co. Ltd.

Main purpose of study: According to the relevant provisions of bioequivalence test, the levothyroxine sodium tablets (trade name: Euthyrox®, specification: 100μg) of Merck Healthcare Germany GmbH as the licensee were selected as the reference preparation, and the test preparation levothyroxine sodium tablets (trade name: Jiaheng®, specification: 100μg) produced and provided by Shenzhen Zhonglian Pharmaceutical Co., Ltd. were subjected to fasting human bioequivalence test to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation levothyroxine sodium tablets (trade name: Jiaheng®, specification: 100μg) and the reference preparation levothyroxine sodium tablets (trade name: Euthyrox®, specification: 100μg) in healthy 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.