AoXin Sunshine (Beijing) Pharmaceutical Technology Co., Ltd.

After oral administration of a single dose of the test preparation (loxoprofen sodium fine granules, manufacturer: Liaoning Haiyi Pharmaceutical Co., Ltd.) and the reference preparation (loxoprofen sodium fine granules, manufacturer: Daiichi Sankyo Co., Ltd.) to Chinese healthy subjects under fasting and postprandial conditions, the pharmacokinetic parameters of loxoprofen were calculated based on the individual blood drug concentration of each subject, and the bioequivalence of the test preparation and the reference preparation was evaluated. At the same time, the safety of the test preparation and the reference preparation in humans was evaluated.

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation ursodeoxycholic acid granules (license holder: Liaoning Haiyi Pharmaceutical Co., Ltd.) and the reference preparation in the fasting/postprandial state. The pharmacokinetic behavior of ursodeoxycholic acid granules (license holder: Tagabe Mitsubishi Manufacturing Co., Ltd., trade name: Urso®) in healthy subjects was evaluated to evaluate the bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation ursodeoxycholic acid granules and the reference preparation ursodeoxycholic acid granules in healthy subjects.

The main purpose is to observe the effects of the test drug and the control drug on renal function, and secondly to observe the differences in metabolic rate and accumulation of the test drug and the control drug by comparing the pharmacokinetic parameters of the two cyclodextrins. Secondary purpose: to observe the bioequivalence of the test drug and the control drug by analyzing the pharmacokinetic parameters of butylphthalide. Statistical analysis of safety indicators such as adverse events, laboratory tests, vital signs, physical examinations, and 12-lead electrocardiograms to evaluate the safety of the test drug and the control drug in the human body except for renal function.