Sinopharm Group Datong Weiqida Zhongkang Pharma Co., Ltd.

Main study objectives Healthy subjects were given a single oral dose of the test preparation Amoxicillin Clavulanate Potassium Tablets (Specification: 0.375g) produced by Sinopharm Weiqida Pharmaceutical Co., Ltd. or the reference preparation Amoxicillin Clavulanate Potassium Tablets (trade name: Augmentin ®; Specification: 0.375g) produced by SmithKline Beecham in the fasting or postprandial state to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects, respectively, and to evaluate the bioequivalence of the two preparations. Secondary study objectives Investigate the safety of the test preparation and the reference preparation in healthy subjects.

Main study objectives: Healthy subjects were given a single oral dose of the test preparation Amoxicillin Clavulanate Potassium Tablets (Specification: 0.375g) produced by Sinopharm Weiqida Pharmaceutical Co., Ltd. or the reference preparation Amoxicillin Clavulanate Potassium Tablets (trade name: Augmentin®; Specification: 0.375g) produced by SmithKline Beecham in the fasting or postprandial state, and the pharmacokinetic parameters of the test preparation and the reference preparation in the healthy subjects were investigated respectively, and the bioequivalence of the two preparations was evaluated. Secondary study objectives: Investigate the safety of the test preparation and the reference preparation in healthy subjects.

Main purpose: Using amoxicillin capsules (trade name: Sawacillin®, specification: 0.25g) produced by LTL Pharmaceutical Co., Ltd. as the reference preparation and amoxicillin capsules (specification: 0.25g) developed by Sinopharm Weiqida Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, double-period, double-crossover clinical trial design was conducted to evaluate the bioequivalence of the two preparations in healthy adult subjects and provide support for the production registration application of the test preparation. Secondary purpose: Preliminary observation of the safety of the test preparation and the reference preparation in healthy adult subjects in China.