Tianjin Jinjin Pharmaceutical Co. Ltd.

Primary Objective: This study used budesonide enteric-coated capsules (4 mg) manufactured and owned by Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd. as the test formulation, and budesonide enteric-coated capsules (4 mg, trade name: NEFECON®) owned by Everest Medicines (Singapore) Pte. Ltd. as the reference formulation, in accordance with relevant regulations for bioequivalence studies, to evaluate the bioequivalence of the test and reference formulations after administration under postprandial conditions. Secondary Objective: To observe the safety of the test and reference formulations, budesonide enteric-coated capsules (NEFECON®), in healthy trial participants.

1. Primary Study Objective: To investigate the relative bioavailability of a single fasting oral dose of the test formulation, dexamethasone acetate tablets [strength: 0.75 mg, manufactured by Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd.], compared to the reference formulation, dexamethasone acetate tablets (DECTANCYL®, strength: 0.5 mg, licensed by SANOFI AVENTIS FRANCE, manufactured by ZENTIVA K.S.), in healthy Chinese adults. The pharmacokinetic parameters of the two formulations were analyzed, and the bioequivalence of the two formulations was evaluated. 2. Secondary Study Objective: To evaluate the safety of a single fasting oral dose of the test formulation and the reference formulation in healthy Chinese adults.

Main study objectives To investigate the relative bioavailability of the test preparation dexamethasone acetate tablets [specification: 0.75 mg, produced by Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd.] and the reference preparation dexamethasone acetate tablets (DECTANCYL®, specification: 0.5 mg, licensed by SANOFI AVENTIS FRANCE, produced by ZENTIVA K.S.) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.