Shandong Luning Pharmaceutical Co., Ltd.

Main research purpose: According to the relevant provisions of bioequivalence test, dapagliflozin tablets (trade name: Andatang, specification: 10mg) with AstraZeneca AB as the licensee were selected as the reference preparation, and the test preparation dapagliflozin tablets (specification: 10mg) produced and provided by Shandong Luning Pharmaceutical Co., Ltd. were subjected to human bioequivalence test 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. Secondary research purpose: To observe the safety of oral administration of the test preparation dapagliflozin tablets (specification: 10mg) and the reference preparation dapagliflozin tablets (trade name: Andatang, specification: 10mg) by healthy volunteers.

Main purpose: To observe the time course of blood drug concentration after a single oral dose of the test preparation lipoic acid tablets (specification: 0.6g, license holder: Shandong Luning Pharmaceutical Co., Ltd.) in healthy subjects in the fasting state, estimate the corresponding pharmacokinetic parameters, and use lipoic acid tablets (trade name: Thioctacid® 600HR, specification: 0.6g, license holder: MEDA Pharma GmbH & Co. KG) as the reference preparation to conduct a formal human bioequivalence test to provide a reference for the registration and clinical application of the drug. Secondary purpose: To observe the safety of the test preparation and reference preparation when the subjects take them orally in the fasting state.

1) Primary objective: To evaluate the bioequivalence of the test formulation (Empagliflozin tablets produced by Shandong Luning Pharmaceutical Co., Ltd., specification: 25 mg) and the reference formulation (Empagliflozin tablets certified by Boehringer Ingelheim International GmbH, specification: 25 mg; trade name: Jardiance®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of Empagliflozin as bioequivalence evaluation indicators. 2) Secondary objective: To observe the safety of the test formulation and the reference formulation under fasting and fed conditions.