Zhuhai Huitongda Medicine Co., Ltd.

Mometasone furoate cream provided by Guangdong Renxiang Pharmaceutical Co., Ltd. was used as the test preparation, and mometasone furoate cream licensed by Organon Pharma (UK) Limited 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 systemic safety of the test preparation.

Main purpose: To conduct a comparative pharmacokinetic study on human fluticasone propionate cream provided by Guangdong Renxiang Pharmaceutical Co., Ltd. as the test preparation and the fluticasone propionate cream licensed by GlaxoSmithKline (Ireland) Limited as the reference preparation. By analyzing the blood drug concentration, the in vivo exposure of the test preparation of fluticasone propionate cream and the reference preparation after topical administration was compared to evaluate the systemic safety of fluticasone propionate cream. Secondary purpose: To observe the safety of topical fluticasone propionate cream on the skin of healthy subjects.

Primary objectives: 1) To determine the dose-duration-effect relationship of a reference formulation of fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) in healthy Chinese volunteers through a preliminary dose-duration-effect exploratory study and to determine the dose-duration (ED50) for subsequent in vivo bioequivalence studies; 2) Based on the results of the preliminary dose-duration-effect exploratory study, appropriate study conditions were designed to conduct a human bioequivalence study using fluticasone propionate cream (0.05%, licensee: Guangdong Renxiang Pharmaceutical Co., Ltd.) produced by Zhejiang Thermo Pharmaceutical Co., Ltd. as the test formulation and the original fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) as the reference formulation. The bioequivalence of the two formulations was evaluated by comparing the pharmacodynamic parameters of the test and reference formulations. Secondary objectives: To observe the safety of topical fluticasone propionate cream in healthy volunteers.