Suzhou Gaomai Pharmaceutical Co., Ltd.

1. A preliminary dose-duration-effect exploratory study was conducted to determine the dose-duration-effect relationship of a reference formulation of hydrocortisone butyrate cream (0.1%, licensed by: CHEPLAPHARM ARZNEIMITTEL GMBH) in healthy Chinese volunteers, 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. A human bioequivalence study was conducted using hydrocortisone butyrate cream (0.1%), manufactured by Jiangsu Wanhe Pharmaceutical Co., Ltd. and provided by Suzhou Gaomai Pharmaceutical Co., Ltd., as the test formulation and hydrocortisone butyrate cream (0.1%), licensed by CHEPLAPHARM ARZNEIMITTEL GMBH, as the reference formulation. The bioequivalence of the two formulations was evaluated by comparing their pharmacodynamic parameters. 3. Blood drug concentration analysis was performed using Hydrocortisone Butyrate Cream (0.1%) produced by Jiangsu Wanhe Pharmaceutical Co., Ltd. and provided by Suzhou Gaomai Pharmaceutical Co., Ltd. as the test formulation and Hydrocortisone Butyrate Cream (0.1%) certified by Cheplapharma Arzneimittel GmbH as the reference formulation. The in vivo exposure ratio of the test formulation to the reference formulation after topical administration was studied to evaluate the safety of the test formulation.

Trial 1: To study the pharmacokinetic characteristics of mometasone furoate cream (0.1% (15g: 15mg)) of Suzhou Gaomai Pharmaceutical Co., Ltd. after single fasting application; using mometasone furoate cream (Elocon®, 0.1%) licensed by Organon Pharma (UK) Limited as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations, and study the difference in in vivo exposure between the test preparation and the reference preparation after topical administration, so as to evaluate the safety of the test preparation; Trial 2: A preliminary dose-duration-effect study, aimed at describing the skin reactions at the administration site after a single topical administration of mometasone furoate cream (Elocon®, 0.1%) licensed by Organon Pharma (UK) Limited to healthy study participants, and obtaining three dose durations ED50, D1 and D2, to provide reference for the key human bioequivalence study; Trial 3: Using mometasone furoate cream (0.1% (1 mg/g) was used as the test preparation; mometasone furoate cream (Elocon®, 0.1%) licensed by Organon Pharma (UK) Limited was used as the reference preparation. The pharmacodynamic parameters of skin reaction colorimetric values at the administration site after a single topical administration of the test preparation (T) or the reference preparation (R) to healthy study participants were compared to evaluate the bioequivalence of the two preparations in humans.

The aim of this study was to investigate the pharmacokinetic characteristics of ketoprofen gel (2.5% (20 g: 0.5 g)) developed by Suzhou Gaomai Pharmaceutical Co., Ltd. and produced by Yaoyuan Biotechnology (Qidong) Co., Ltd. after single fasting topical application. Ketoprofen gel (Fastone®, 1 g: 0.025 g) produced by A.Menarini Manufacturing Logistics and Services S.r.l. was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the bioequivalence of the two preparations in humans was evaluated, and the skin reactivity and safety of the test preparation (T) and the reference preparation (R) after topical administration were studied.