Guangdong Shunfeng Pharmaceutical Co., Ltd.

1) The dose-duration-effect relationship of the reference preparation of methylprednisolone acetonide cream (specification: 0.1%, licensed by Leo Pharma A/S, trade name: Advantan®) 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 test were determined; 2) Based on the results of the preliminary dose-duration-effect exploratory study, appropriate research conditions were designed, and the methylprednisolone acetonide cream (specification: 0.1% (15 g)) provided by Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd. was used as the test preparation, and the methylprednisolone acetonide cream (specification: 0.1%, trade name: Advantan®) licensed by Leo Pharma A/S was used as the reference preparation for human bioequivalence testing. The pharmacodynamic parameters of the two preparations were compared to evaluate the bioequivalence of the two preparations. 3) Using methylprednisolone acetonide cream (specification: 0.1% (15 g)) provided by Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd. as the test preparation and methylprednisolone acetonide cream (specification: 0.1%; trade name: Advantan®) certified by Leo Pharma A/S 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 bioequivalence of crisaborole ointment (specification: 20 mg crisaborole per gram of ointment, 30 g/tube, test preparation) provided by Guangdong Huarun Shunfeng Pharmaceutical Co., Ltd. and crisaborole ointment (trade name: Sutanming®, specification: 20 mg crisaborole per gram of ointment) produced by Anacor Pharmaceuticals, Inc. and Pharmacia and Upjohn Company LLC under the condition of single administration on an empty stomach, and to provide a basis for the registration application of the test preparation. Secondary objective: To evaluate the safety of crisaborole ointment by observing the safety indicators of the test preparation and the reference preparation after a single application in healthy subjects.