/ CompletedNot Applicable 丙酸氟替卡松乳膏（0.05%）在中国健康受试者中生物等效性预试验
[Translation] Preliminary bioequivalence study of fluticasone propionate cream (0.05%) in Chinese healthy subjects
主要目的：结合初步剂量持续时间-效应探索研究结果（ED50为1.0h），设计合适的研究条件，以江苏万禾制药有限公司生产、苏州高迈药业有限公司提供的丙酸氟替卡松乳膏（规格：0.05%(30g：15mg)）为受试制剂，以GlaxoSmithKline (Ireland) Limited持证的丙酸氟替卡松乳膏（规格：0.05%(15g：7.5mg)；商品名：Cutivate）为参比制剂进行人体生物等效性预试验，比较两制剂的药效学参数，为正式试验设计提供参考依据。
次要目的：观察健康受试者皮肤外用丙酸氟替卡松乳膏的安全性。
[Translation] Main purpose: Combined with the results of the preliminary dose-duration-effect exploration study (ED50 is 1.0h), appropriate research conditions were designed, and fluticasone propionate cream (specification: 0.05% (30g: 15mg)) produced by Jiangsu Wanhe Pharmaceutical Co., Ltd. and provided by Suzhou Gaomai Pharmaceutical Co., Ltd. was used as the test preparation, and fluticasone propionate cream (specification: 0.05% (15g: 7.5mg); trade name: Cutivate) certified by GlaxoSmithKline (Ireland) Limited was used as the reference preparation for human bioequivalence pre-test, and the pharmacodynamic parameters of the two preparations were compared to provide a reference for the formal test design.
Secondary purpose: To observe the safety of fluticasone propionate cream for external use on the skin of healthy subjects.
/ Not yet recruitingNot Applicable [Translation] Human bioequivalence study of mometasone furoate cream
试验1：旨在研究单次空腹涂抹使用要智达（武汉）医药有限公司的糠酸莫米松乳膏（0.1%（30 g：30 mg））的药代动力学特征；以Organon Pharma(UK)Limited持证的糠酸莫米松乳膏（Elocon®，0.1%）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，研究局部给药后受试制剂与参比制剂的体内暴露量差异，从而评价受试制剂的安全性； 试验2：初步的剂量持续时间—效应研究，旨在描述健康研究参与者局部单次给予Organon Pharma(UK)Limited持证的糠酸莫米松乳膏（Elocon®，0.1%）后给药部位的皮肤反应，获取三个剂量持续时间ED50、D1和D2，为关键性人体生物等效性研究提供参考； 试验3：以要智达（武汉）医药有限公司的糠酸莫米松乳膏（0.1%（30 g：30 mg））为受试制剂；以Organon Pharma(UK)Limited持证的糠酸莫米松乳膏（Elocon®，0.1%）为参比制剂，较健康研究参与者局部单次给予受试制剂（T）或参比制剂（R）后给药部位的药效学参数皮肤反应色度值，评价两制剂的人体生物等效性。
[Translation] Experiment 1: This study aimed to investigate the pharmacokinetic characteristics of a single, fasting application of mometasone furoate cream (0.1% (30 g: 30 mg)) from Yaozhida (Wuhan) Pharmaceutical Co., Ltd. Using mometasone furoate cream (Elocon®, 0.1%) from Organon Pharma (UK) Limited as a reference formulation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ were compared between the two formulations to study the difference in in vivo exposure between the test and reference formulations after topical administration, thereby evaluating the safety of the test formulation. Experiment 2: This preliminary dose-duration-effect study aimed to describe the skin response at the administration site after a single topical administration of mometasone furoate cream (Elocon®, 0.1%) from Organon Pharma (UK) Limited to healthy study participants, obtaining three dose durations (ED50, D1, and D2) to provide a reference for pivotal human bioequivalence studies. Experiment 3: Mometasone furoate cream (0.1% (30 g: 30 mg)) from Yaozhida (Wuhan) Pharmaceutical Co., Ltd. was used as the test formulation; mometasone furoate cream (Elocon®, 0.1%) from Organon Pharma (UK) Limited was used as the reference formulation. The pharmacodynamic parameters of skin reaction color values at the application site after a single local administration of the test formulation (T) or the reference formulation (R) to healthy study participants were compared to evaluate the bioequivalence of the two formulations in humans.
100 Clinical Results associated with Yaozhida (Wuhan) Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Yaozhida (Wuhan) Pharmaceutical Co., Ltd.
