Jiangsu Desano Pharmaceutical Co. Ltd.

Primary Objective: To investigate the pharmacokinetic characteristics of crisaborole ointment (2% (30g: 600mg)) produced by Jiangsu Desano Pharmaceutical Co., Ltd. and crisaborole ointment (20mg crisaborole (2%) per gram) produced by licensee Anacor Pharmaceuticals, LLC. under fasting conditions and to evaluate the bioequivalence of the two formulations. Secondary Objective: To evaluate the safety of the test and reference formulations of crisaborole ointment after single-dose administration in healthy volunteers.

(1) The dose-duration-effect relationship of mometasone furoate cream (0.1%; licensee: Organon Pharma (UK) Limited) in healthy Chinese subjects was determined through a preliminary dose-duration-effect study pilot to provide a decision basis for the formal trial. The study aims to determine the dose-duration (ED50) in subsequent bioequivalence studies. (2) Based on the results of the dose-duration-effect exploration study, appropriate experimental conditions were designed to conduct a human bioequivalence study using mometasone furoate cream [0.1% (15g: 15mg)] produced by Jiangsu Desano Pharmaceutical Co., Ltd. as the test preparation and mometasone furoate cream (Elocon®; 0.1%) held by Organon Pharma (UK) Limited as the reference preparation. The bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters. (3) The in vivo exposure ratio of the test preparation to the reference preparation after topical administration was studied to evaluate the safety of the test preparation.

The main purpose of the study is to use the levamlodipine besylate tablets (2.5 mg) certified by Jiangsu Desano Pharmaceutical Co., Ltd. as the test preparation and the amlodipine besylate tablets (trade name: Norvasc, 5 mg) certified by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior in healthy Chinese subjects is compared to evaluate the bioequivalence of the two preparations. Secondary purpose of the study: 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 healthy Chinese subjects.