China Union Chempharma (Suzhou) Co., Ltd.

Main purpose: Using Sacubitril-Valsartan Sodium Tablets (Specification: 200mg, including 97mg Sacubitril/103mg Valsartan) of Suzhou Third Pharmaceutical Factory Co., Ltd. as the test preparation and Sacubitril-Valsartan Sodium Tablets (Specification: 200mg, including 97mg Sacubitril/103mg Valsartan) of Novartis Pharma Schweiz AG as the reference preparation, according to the relevant provisions of bioequivalence test, to investigate the bioequivalence of the two preparations in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary study objective To evaluate the pharmacokinetic characteristics and bioequivalence of a single oral dose of the test formulation of cefadroxil dry suspension (specification: 500mg/5mL, applicant: Suzhou Third Pharmaceutical Factory Co., Ltd.) and the reference formulation (trade name: Cefadroxil®, specification: 500mg/5mL, licensee: Lupin Pharmaceuticals, Inc.) in healthy Chinese adult study participants under fasting and postprandial conditions. Secondary study objective To investigate the safety of the test formulation of cefadroxil dry suspension (specification: 500mg/5mL) and the reference formulation (trade name: Cefadroxil®, specification: 500mg/5mL) in healthy Chinese adult study participants.

The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behaviors of the test preparation Cefditoren Pivoxil Granules (certificate holder: Suzhou Shengda Pharmaceutical Co., Ltd.) and the reference preparation Cefditoren Pivoxil Granules (certificate holder: Meiji Seika Pharma Co., Ltd.) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.