Shandong Linuo Pharmaceutical Co. Ltd.

According to the relevant provisions of bioequivalence tests, Empagliflozin Metformin Sustained-Release Tablets (trade name: Synjardy® XR, specification: 25mg/1000mg) licensed by Boehringer Ingelheim Pharmaceuticals, Inc. and produced by Patheon Pharmaceuticals Inc. were selected as the reference preparation. The human bioequivalence test of the test preparation Empagliflozin Metformin Sustained-Release Tablets (specification: 25mg/1000mg) provided by Shandong Linuo Pharmaceutical Co., Ltd. was conducted on fasting and postprandial administration 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 and postprandial administration conditions. At the same time, the safety of the test preparation and the reference preparation after oral administration was observed in healthy subjects.

Main research objectives: To investigate the relative bioavailability of the test preparation lurasidone hydrochloride tablets [Specification: 40 mg (calculated as C28H36N4O2S?HCl)] and the reference preparation [trade name: Luo Shuda®, specification: 40 mg (calculated as C28H36N4O2S?HCl)] in healthy Chinese subjects after a single oral administration (fasting/after meals), analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary research objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after a single oral administration (fasting/after meals).

To investigate whether there are differences in the extent and rate of absorption of the test preparation piracetam tablets (Shandong Linuo Pharmaceutical Co., Ltd., specification: 0.8g) and the reference preparation piracetam tablets (trade name: Nootropil®, specification: 0.8g) taken orally on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.