/ RecruitingNot Applicable 丙酸氟替卡松乳膏生物等效性研究与人体药代动力学对比研究
[Translation] Comparative study on bioequivalence of fluticasone propionate cream and pharmacokinetics in humans
(1)通过初步剂量持续时间-效应的探索研究测定以GlaxoSmithKline（Ireland）Limited持证的丙酸氟替卡松乳膏（规格：0.05%(15 g:7.5 mg)）为参比制剂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）和预期满足AUEC值的D2/D1最小比值的受试者比例；（2）结合初步剂量持续时间-效应探索研究结果，以浙江寰领医药科技有限公司提供的丙酸氟替卡松乳膏（规格：0.05%(15 g:7.5 mg)）为受试制剂，以GlaxoSmithKline（Ireland）Limited持证的丙酸氟替卡松乳膏（规格：0.05%(15 g:7.5 mg)）为参比制剂进行人体生物等效性试验，通过比较两制剂的药效学参数，评价两制剂的生物等效性；（3）研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂在中国健康受试者中的安全性。
[Translation] (1) A preliminary dose-duration-effect exploratory study was conducted to determine the dose-duration-effect relationship of the reference preparation, fluticasone propionate cream (specification: 0.05% (15 g: 7.5 mg)) licensed by GlaxoSmithKline (Ireland) Limited, in healthy Chinese subjects, and to determine the dose-duration (ED50) and the proportion of subjects expected to meet the minimum D2/D1 ratio of the AUEC value in the subsequent in vivo bioequivalence study; (2) Based on the results of the preliminary dose-duration-effect exploratory study, the fluticasone propionate cream (specification: 0.05% (15 g: 7.5 mg)) provided by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. was used as the test preparation, and the fluticasone propionate cream (specification: 0.05% (15 g: 7.5 mg) licensed by GlaxoSmithKline (Ireland) Limited) was used as the reference preparation. (1) The bioequivalence study was conducted on the test preparation using the reference preparation (mg/ml) as the reference preparation, and the bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters of the two preparations; (2) The in vivo exposure ratio of the test preparation to the reference preparation after local administration was studied, so as to evaluate the safety of the test preparation in healthy Chinese subjects.
/ RecruitingNot Applicable 糠酸莫米松乳膏生物等效性研究与人体药代动力学对比研究
[Translation] Comparative study on bioequivalence of mometasone furoate cream and its pharmacokinetics in humans
（1）通过初步剂量持续时间-效应的探索研究测定以Organon Pharma(UK) Limited持证的糠酸莫米松乳膏（规格：0.1%（30 g: 30 mg）)为参比制剂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）和预期满足AUEC值的D2/D1最小比值的受试者比例；（2）结合初步剂量持续时间-效应探索研究结果，以浙江寰领医药科技有限公司提供的糠酸莫米松乳膏（规格：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（规格：0.1%（30 g: 30 mg）)为参比制剂进行人体生物等效性试验，通过比较两制剂的药效学参数，评价两制剂的生物等效性；（3）研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂的安全性。
[Translation] (1) A preliminary dose-duration-effect exploratory study was conducted to determine the dose-duration-effect relationship of mometasone furoate cream (specification: 0.1% (30 g: 30 mg)) licensed by Organon Pharma (UK) Limited as the reference preparation in healthy Chinese subjects, and to determine the dose-duration (ED50) and the proportion of subjects expected to meet the minimum D2/D1 ratio of the AUEC value in the subsequent in vivo bioequivalence study; (2) Based on the results of the preliminary dose-duration-effect exploratory study, mometasone furoate cream (specification: 0.1% (30 g: 30 mg)) provided by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. was used as the test preparation, and mometasone furoate cream (specification: 0.1% (30 g: 30 mg)) licensed by Organon Pharma (UK) Limited was used as the reference preparation in healthy Chinese subjects. (1) The bioequivalence study was conducted on the reference preparation using 1 mg) as the test preparation and the bioequivalence of the two preparations was evaluated by comparing the pharmacodynamic parameters of the two preparations; (2) The in vivo exposure ratio of the test preparation to the reference preparation after local administration was studied to evaluate the safety of the test preparation.
/ Active, not recruitingNot Applicable [Translation] Study on the bioequivalence of diclofenac diethylamine emulsion in healthy volunteers
主要目的：以浙江寰领医药科技有限公司提供的双氯芬酸二乙胺乳胶剂（规格：1%（20 g:0.2 g，以双氯芬酸钠计））为受试制剂，以GSK Consumer Healthcare Schweiz AG持证的双氯芬酸二乙胺乳胶剂（商品名：扶他林®，规格：1%（20 g:0.2 g，以双氯芬酸钠计）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。
次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Diclofenac diethylamine emulsion (specification: 1% (20 g: 0.2 g, calculated as diclofenac sodium)) provided by Zhejiang Huanling Pharmaceutical Technology Co., Ltd. was used as the test preparation, and diclofenac diethylamine emulsion (trade name: Voltaren®, specification: 1% (20 g: 0.2 g, calculated as diclofenac sodium) certified by GSK Consumer Healthcare Schweiz AG was used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Huanling Pharmaceutical Technology Co., Ltd.
