Shandong Lukang Pharmaceutical Group Saite Co., Ltd.

To investigate whether there are differences in the extent and rate of absorption between the test preparation sacubitril-valsartan sodium tablets (Shandong Lukang Pharmaceutical Group Saite Co., Ltd., specification: 200 mg, sacubitril/valsartan (97 mg/103 mg)) and the reference preparation sacubitril-valsartan sodium tablets (trade name: Nusintuo ®, Novartis Pharma Schweiz AG, specification: 200 mg, sacubitril/valsartan (97 mg/103 mg)) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary objective: To study the relative bioavailability of dapagliflozin tablets 10 mg (test preparation) produced by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. and original dapagliflozin tablets 10 mg (FORXIGA/Andatang, reference preparation) of AstraZeneca AB as the licensee in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence between the test preparation and the reference preparation. Secondary objective: To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.

Main purpose: This study used finasteride tablets developed by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence tests, Proscar licensed by Organon Pharma (UK) Limited was used as the reference preparation. Human bioequivalence tests were conducted in fasting/postprandial states to evaluate the bioequivalence of the test preparation and the reference preparation in healthy male subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy male subjects.