Hunan Zhengtai Jinhu Pharmaceutical Co., Ltd.

Main objectives: 1. To evaluate the safety and tolerability of HRN01 tablets after single and multiple oral administration in healthy subjects; 2. To evaluate the effect of food (high-fat and high-calorie meal) on the pharmacokinetics of HRN01 tablets. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of HRN01 tablets after single and multiple oral administration in healthy subjects; 2. To evaluate the metabolism and excretion characteristics of HRN01 tablets in healthy subjects; 3. To evaluate the effect of single administration of HRN01 tablets on the QTc interval of healthy subjects; 4. To evaluate the safety and tolerability of oral administration of HRN01 tablets in healthy subjects in the postprandial state (high-fat and high-calorie meal). Exploratory objectives: To explore the pharmacodynamic indicators of HRN01 tablets after multiple oral administration in healthy subjects.

Main research purpose: According to the relevant provisions of bioequivalence test, Hainan Xiansheng Pharmaceutical Co., Ltd. was selected as the reference preparation for the test preparation Aguratimod Tablets (Specification: 25mg) produced and provided by Hunan Mingrui Pharmaceutical Co., Ltd. to conduct a human bioequivalence test on fasting administration, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Aguratimod Tablets (Specification: 25mg) and the reference preparation Aguratimod Tablets (Trade Name: Aguratimod, Specification: 25mg) by healthy volunteers.

(1) The dose-duration-effect relationship of the reference preparation of desonide ointment (specification: 0.05%; licensee: Padagis US LLC; trade name: Desonide®) in Chinese healthy subjects was determined through a preliminary dose-duration-effect exploratory study, and the dose-duration (ED50) and the proportion of subjects expected to meet the minimum D2/D1 ratio of the AUEC value in the subsequent in vivo bioequivalence study were determined; (2) Based on the results of the preliminary dose-duration-effect exploratory study, appropriate research conditions were designed, and the desonide ointment (specification: 0.05%) provided by Hunan Mingrui Pharmaceutical Co., Ltd. was used as the test preparation, and the desonide ointment (specification: 0.05%; trade name: Desonide®) licensed by Padagis US LLC was used as the reference preparation for human bioequivalence testing. The bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters of the two preparations. (3) Desonide ointment (specification: 0.05%) provided by Hunan Mingrui Pharmaceutical Co., Ltd. was used as the test preparation, and desonide ointment (specification: 0.05%; trade name: Desonide®) certified by Padagis US LLC was used as the reference preparation. The in vivo exposure ratio of the test preparation and the reference preparation after topical administration was studied to evaluate the safety of the test preparation.