Hunan Tian Ji Thatched Cottage Pharmaceutical Co. Ltd.

Primary objective: To investigate the relative bioavailability of a single oral (fasting/postprandial) test preparation of sacubitril-valsartan sodium tablets [Specification: 200 mg based on sacubitril-valsartan (sacubitril 97 mg/valsartan 103 mg)] and a reference preparation [Trade name: Nusintuo, Specification: 200 mg based on sacubitril-valsartan (sacubitril 97 mg/valsartan 103 mg)] in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. Secondary objective: To evaluate the safety of a single oral (fasting/postprandial) test preparation and reference preparation in healthy Chinese adult subjects.

This study investigated the pharmacokinetic characteristics of a single oral dose of oseltamivir phosphate dry syrup (test preparation, specification: 30 mg/bag, calculated as oseltamivir) produced by Hunan Tianji Caotang Pharmaceutical Co., Ltd. or oseltamivir phosphate dry syrup (reference preparation, trade name: Tamiflu®, specification: 3%, 30 g, calculated as oseltamivir) certified and produced by Chugai Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions, evaluated the bioequivalence and safety of the two preparations, and provided a basis for the registration application of the test preparation.

The main purpose of the study was to evaluate the relative bioavailability and bioequivalence of the test preparation and the reference preparation when the test preparation and the reference preparation were administered in the fasting and fed state, respectively, using atorvastatin calcium tablets (20 mg/tablet) developed by Hunan Tianji Caotang Pharmaceutical Co., Ltd. as the test preparation and atorvastatin calcium tablets (20 mg/tablet, Lipitor®) produced by Pfizer Ireland Pharmaceuticals and packaged by Parke-Davis Division of Pfizer Inc. as the reference preparation. The secondary purpose of the study was to observe the safety of the test preparation in healthy subjects.