Hunan Zhengtai Jinhu Pharmaceutical Co., Ltd.

(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.

Primary objective To compare the differences in the extent and rate of absorption of finerenone tablets (10 mg) produced by Hunan Mingrui Pharmaceutical Co., Ltd. and finerenone tablets (10 mg, trade name: Kerendia®) licensed by Bayer AG in healthy adults under fasting conditions, and to evaluate their bioequivalence. Secondary objective To evaluate the safety of finerenone tablets (10 mg) produced by Hunan Mingrui Pharmaceutical Co., Ltd. and finerenone tablets (10 mg, trade name: Kerendia®) licensed by Bayer AG in healthy adults under fasting conditions.

Main purpose of study: According to the relevant provisions of bioequivalence test, Anacor Pharmaceuticals, Inc. is the licensee of crisaborole ointment (trade name: Sutanming®, specification: 2%) as the reference preparation, and the test preparation crisaborole ointment (specification: 2%) produced and provided by Hunan Mingrui Pharmaceutical Co., Ltd. is used for fasting topical administration of human bioequivalence test, 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 topical conditions. Secondary purpose of study: To observe the safety of the test preparation crisaborole ointment (specification: 2%) and the reference preparation crisaborole ointment (trade name: Sutanming®, specification: 2%) in fasting topical administration of healthy volunteers.