/ RecruitingNot Applicable 单中心、随机、开放、单次给药的丙酸氟替卡松乳膏在中国健康受试者中的生物等效性研究
[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of fluticasone propionate cream in Chinese healthy subjects
主要目的：1）通过血药浓度分析，比较丙酸氟替卡松乳膏受试制剂与参比制剂局部用药后的体内暴露量，评价丙酸氟替卡松乳膏的系统安全性；
2）结合初步剂量持续时间-效应探索研究结果，设计合适的研究条件，以浙江赛默制药有限公司生产的丙酸氟替卡松乳膏（0.05%，持证商：浙江百代医药科技有限公司）为受试制剂，以原研丙酸氟替卡松乳膏（Cutivate®，0.05%，GlaxoSmithKline (Ireland) Limited）为参比制剂进行人体生物等效性试验，通过比较受试制剂与参比制剂的药效学参数，评价两制剂的生物等效性。
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 objectives: 1) Compare the in vivo exposure of the test preparation and the reference preparation of fluticasone propionate cream after topical administration through blood drug concentration analysis to evaluate the systemic safety of fluticasone propionate cream;
2) Combined with the results of the preliminary dose-duration-effect exploration study, design appropriate research conditions, use fluticasone propionate cream (0.05%, licensee: Zhejiang Baidai Pharmaceutical Technology Co., Ltd.) produced by Zhejiang Thermo Pharmaceutical Co., Ltd. as the test preparation, and use the original fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) as the reference preparation to conduct human bioequivalence test, and compare the pharmacodynamic parameters of the test preparation and the reference preparation to evaluate the bioequivalence of the two preparations.
Secondary objectives: Observe the safety of topical fluticasone propionate cream on the skin of healthy subjects.
/ CompletedNot Applicable [Translation] An exploratory study on the initial dose-duration-effect of fluticasone propionate cream
主要目的：通过初步剂量持续时间-效应的探索研究测定丙酸氟替卡松乳膏参比制剂（Cutivate®，0.05%，GlaxoSmithKline (Ireland) Limited）在中国健康受试者中的剂量持续时间-效应关系，确定后续体内生物等效性试验中的剂量持续时间（ED50）。
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] Primary objective: To determine the dose-duration-effect relationship of the reference fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) in healthy Chinese subjects through a preliminary dose-duration-effect exploratory study and to determine the dose-duration (ED50) in subsequent in vivo bioequivalence studies.
Secondary objective: To observe the safety of topical fluticasone propionate cream for skin application in healthy subjects.
/ Active, not recruitingNot Applicable 单中心、随机、开放、单次给药的糠酸莫米松乳膏人体生物等效性研究（药代动力学对比研究/初步剂量持续时间-效应研究/关键体内生物等效性研究）
[Translation] A single-center, randomized, open-label, single-dose bioequivalence study of mometasone furoate cream in humans (pharmacokinetic comparison study/preliminary dose-duration-effect study/pivotal in vivo bioequivalence study)
主要目的：1) 通过血药浓度分析，比较糠酸莫米松乳膏受试制剂与参比制剂局部用药后的体内暴露量，评价糠酸莫米松乳膏的系统安全性；
2)通过观测糠酸莫米松使皮肤血管收缩致皮肤变白的作用，探索达到半数最大效应（Emax）的剂量持续时间（ED50）；再在ED50剂量持续时间下评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的：观察健康受试者皮肤外用糠酸莫米松乳膏的安全性。
[Translation] Main objectives: 1) To compare the in vivo exposure of the test and reference furoate creams after topical administration through blood drug concentration analysis, and evaluate the systemic safety of furoate creams;
2) To explore the dose duration (ED50) to achieve the half-maximal effect (Emax) by observing the effect of furoate on skin vasoconstriction and skin whitening; and then evaluate the bioequivalence of the test and reference preparations in healthy subjects at the ED50 dose duration.
Secondary objectives: To observe the safety of furoate creams for topical application on the skin of healthy subjects.
100 Clinical Results associated with Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.
