Shandong Boshan Pharmaceutical Co., Ltd.

Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states, using the benzhexol hydrochloride tablets (specification: 2 mg) of Watson Laboratories Inc as the reference preparation and the benzhexol hydrochloride tablets (specification: 2 mg) developed by Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd. as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Main research purpose The human bioavailability study was conducted by taking a single oral dose of isosorbide dinitrate tablets (specification: 5 mg) held by Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd. and isosorbide dinitrate tablets (trade name: ISORDIL®; specification: 5 mg) held by BAUSCH HEALTH US LLC in healthy subjects under fasting state, to investigate the pharmacokinetic parameters and coefficient of variation of isosorbide dinitrate and its metabolites, verify the rationality of the settings such as the blood sampling time point of the pharmacokinetic curve, the sample size of the subjects, and the test cycle interval, and provide a reference for the formulation of the formal test plan. Secondary research purpose During the study, the safety of isosorbide dinitrate tablets in healthy humans was preliminarily evaluated by the changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.

The main purpose of the study is to study the absorption rate and extent of metformin hydrochloride sustained-release tablets (specification: 0.5 g; test preparation) of Shandong Boshan Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, using metformin hydrochloride sustained-release tablets (trade name: Glucophage XR; specification: 0.5 g) held by Merck Serono Limited as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy subjects.