Hunan Qianjin Xieli Pharmaceutical Co., Ltd.

Primary objective: Using sacubitril-valsartan sodium tablets (specification: 200 mg) developed by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. as the test preparation and sacubitril-valsartan sodium tablets (trade name: Nuxintu®, specification: 200 mg) certified by Novatris Pharma Schweiz AG as the reference preparation, the pharmacokinetic behavior in healthy Chinese volunteers was compared according to the relevant provisions of the bioequivalence test, and the bioequivalence of the two preparations was evaluated. Secondary objective: To evaluate the safety of the test preparation and the reference preparation after a single oral administration on an empty stomach or after a meal in healthy Chinese volunteers.

Sacubitril-valsartan sodium tablets (specification: 200 mg) developed by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. were used as the test preparation, and sacubitril-valsartan sodium tablets (trade name: EntrestoTM, specification: 200 mg) produced by Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting and postprandial conditions were investigated, and the bioequivalence of the two preparations under fasting and postprandial conditions was preliminarily evaluated, providing a basis for the design of the number of cases, blood collection points and washout period of the formal bioequivalence trial plan in the later stage.

Primary objective: To evaluate whether oral administration of amlodipine besylate tablets produced by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. to healthy Chinese adults is bioequivalent to the original formulation. Secondary objective: To evaluate the safety of oral administration of amlodipine besylate tablets produced by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. to healthy Chinese adults.