Guoyao Group Rongsheng Pharmaceutical Co. Ltd.

This study aims to study the pharmacokinetic characteristics of a single-dose oral fasting and postprandial dose of Asartan Potassium Tablets (80 mg) licensed by Sinopharm Rongsheng Pharmaceutical Co., Ltd., and Asartan Potassium Tablets (Edabib®, 80 mg) licensed by Takeda Pharma A/S as the reference preparation, compare the pharmacokinetic parameters of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the test preparation and the reference preparation in healthy subjects.

Main research purposes: Examine a single oral dose (fasting/after meal) of the test preparation Imidapril Hydrochloride Tablets (specification: 5mg, produced by Sinopharm Rongsheng Pharmaceutical Co., Ltd.) and the reference preparation Imidapril Hydrochloride Tablets (specification: 5mg, Licensed by Mitsubishi Tanbei Pharmaceutical Co., Ltd.), the relative bioavailability of the two preparations in healthy humans in China was analyzed, and the pharmacokinetic parameters of the two preparations were analyzed to evaluate the bioequivalence of the two preparations. Secondary research purpose: 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 Chinese adult healthy subjects.

Main research purposes: Examine a single oral dose (fasting/after meal) of the test preparation Imidapril Hydrochloride Tablets (specification: 10 mg, produced by Sinopharm Rongsheng Pharmaceutical Co., Ltd.) and the reference preparation Imidapril Hydrochloride Tablets (specification: 10 mg, Licensed by Mitsubishi Tanbei Pharmaceutical Co., Ltd.), the relative bioavailability of the two preparations in healthy humans in China was analyzed, and the pharmacokinetic parameters of the two preparations were analyzed to evaluate the bioequivalence of the two preparations. Secondary research purpose: 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 Chinese adult healthy subjects.