Jiangsu Yong'an Pharmaceutical Co Ltd.

Using healthy participants in a Chinese trial, this study employed a self-controlled crossover design to determine the plasma concentrations of amlodipine, valsartan, and hydrochlorothiazide in healthy participants over time after administration of the test formulation of amlodipine, valsartan, and hydrochlorothiazide tablets. Corresponding pharmacokinetic parameters were estimated, and the bioequivalence between the formulations was evaluated using amlodipine, valsartan, and hydrochlorothiazide tablets (trade name: Exforge HCT®, strengths: 5/160/12.5 mg) manufactured by Novartis Farma S.p.A., licensed by Novartis Pharmaceuticals Corporation. The safety of amlodipine, valsartan, and hydrochlorothiazide tablets in healthy participants in the Chinese trial was also observed.

Main study objectives: To investigate the relative bioavailability of a single oral (fasting/postprandial) test formulation of sacubitril-valsartan sodium tablets [Specification: 200 mg (sacubitril 97 mg/valsartan 103 mg), produced by Jiangsu Yongan Pharmaceutical Co., Ltd.] and a reference formulation [Trade name: Nusintuo, Specification: 200 mg (sacubitril 97 mg/valsartan 103 mg), produced by Novartis Farma S.p.A.] in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two formulations, evaluate the bioequivalence of the two formulations, and provide a reference for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of a single oral (fasting/postprandial) test formulation and reference formulation in healthy adult Chinese subjects.

The main purpose of the study is to investigate the relative bioavailability of the test preparation Iguratimod tablets (specification: 25 mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) and the reference preparation Iguratimod tablets (trade name: Edesin®, specification: 25 mg, produced by Hainan Xiansheng Pharmaceutical Co., Ltd. with a license) in healthy Chinese subjects after a single oral dose (fasting/postprandial), 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 test preparation Iguratimod tablets. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese healthy adult subjects after a single oral dose (fasting/postprandial).