/ Active, not recruitingNot Applicable [Translation] Formal bioequivalence study of fluticasone propionate cream in humans
主要目的：1.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）；
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：浙江高跖医药科技股份有限公司）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。
[Translation] Main objectives: 1. To determine the dose-duration-effect relationship of the reference preparation of fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) in healthy Chinese subjects through a preliminary dose-duration-effect exploration study, and to determine the dose-duration (ED50) in the subsequent in vivo bioequivalence study;
2. Based on the results of the preliminary dose-duration-effect exploration study, design appropriate research conditions, use the fluticasone propionate cream (0.05%, licensee: Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd.) produced by Zhejiang Thermo Pharmaceutical Co., Ltd. as the test preparation, and the original fluticasone propionate cream (Cutivate®, 0.05%, GlaxoSmithKline (Ireland) Limited) as the reference preparation to conduct a human bioequivalence study, and evaluate the bioequivalence of the two preparations by comparing the pharmacodynamic parameters of the test preparation and the reference preparation.
/ CompletedNot Applicable 盐酸丁螺环酮片（15mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两制剂、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of buspirone hydrochloride tablets (15 mg) in healthy Chinese subjects under fasting and fed conditions
以浙江高跖医药科技股份有限公司的盐酸丁螺环酮片为受试制剂；并以Teva Pharmaceuticals USA Inc.持证的盐酸丁螺环酮片为参比制剂，进行人体相对生物利用度和生物等效性评价
[Translation] Buspirone hydrochloride tablets from Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd. were used as the test preparation, and buspirone hydrochloride tablets certified by Teva Pharmaceuticals USA Inc. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
/ CompletedNot Applicable 艾普拉唑肠溶片在健康受试者中随机、开放、单剂量、两制剂、交叉对照的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of ilaprazole enteric-coated tablets in healthy volunteers
以浙江高跖医药科技股份有限公司的艾普拉唑肠溶片为受试制剂；并以丽珠集团丽珠制药厂持证的艾普拉唑肠溶片为参比制剂，进行生物等效性正式试验。
[Translation] A formal bioequivalence test was conducted using ilaprazole enteric-coated tablets produced by Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd. as the test preparation, and ilaprazole enteric-coated tablets certified by Livzon Pharmaceutical Factory of Livzon Group as the reference preparation.
100 Clinical Results associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
100 Deals associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
