Tianmen Kejie Pharmacy Co. Ltd.

Using mometasone furoate cream (Elocon®, 0.1% (30 g: 30 mg)) manufactured by Organon Heist bv and licensed by Organon Pharma (UK) Limited as the reference formulation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to study the difference in in vivo exposure after local administration of the test formulation and the reference formulation, thereby evaluating the safety of the test formulation.

Objective 1: A preliminary dose-duration-response study was conducted to describe the skin response at the administration site following a single topical administration of mometasone furoate cream (Elocon®, 0.1% (30 g: 30 mg)) manufactured by Organon Heist bv and licensed by Organon Pharma (UK) Limited, to obtain three dose durations (ED50, D1, and D2) to provide a reference for pivotal human bioequivalence studies. Objective 2: To conduct a pivotal in vivo bioequivalence comparison of the investigational drug and the control drug, using mometasone furoate cream (0.1% (15 g: 15 mg)) manufactured by Hubei Kejie Pharmaceutical Co., Ltd. and Hubei Ketian Pharmaceutical Co., Ltd. as the test formulation; and mometasone furoate cream (Elocon®, 0.1% (30 g: 30 mg)) manufactured by Organon Pharma (UK) Limited and Organon Heist bv as the reference formulation, comparing the pharmacodynamic parameters of skin reaction color values at the administration site after a single topical administration of the test formulation (T) or the reference formulation (R) to evaluate the human bioequivalence of the two formulations.