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/ CompletedNot Applicable 昂丹司琼口溶膜随机、开放、交叉设计在中国健康受试者中的生物等效性研究
[Translation] A randomized, open-label, crossover study of the bioequivalence of ondansetron orodispersible film in Chinese healthy subjects
主要目的:以浙江恒研医药科技有限公司的昂丹司琼口溶膜为受试制剂;并以Norgine Pharmaceuticals Limited持证的昂丹司琼口溶膜为参比制剂,进行生物等效性正式试验。
[Translation] Main purpose: To conduct a formal bioequivalence study using the ondansetron orodispersible film produced by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd. as the test preparation and the ondansetron orodispersible film produced by Norgine Pharmaceuticals Limited as the reference preparation.
/ CompletedNot Applicable 氟伐他汀钠缓释片在健康受试者中随机、开放、单剂量、两制剂、交叉对照空腹及餐后状态下的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled bioequivalence study of fluvastatin sodium extended-release tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹及餐后状态下单次口服受试制剂氟伐他汀钠缓释片(规格:80mg,浙江恒研医药科技有限公司持证)与参比制剂氟伐他汀钠缓释片(商品名:Lescol® XL,规格:80mg,Novartis Pharmaceuticals Corp持证)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性。
[Translation] Main objective: To study the pharmacokinetics of the test preparation fluvastatin sodium sustained-release tablets (specification: 80 mg, licensed by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.) and the reference preparation fluvastatin sodium sustained-release tablets (trade name: Lescol® XL, specification: 80 mg, licensed by Novartis Pharmaceuticals Corp) in healthy adult subjects after a single oral dose in fasting and fed states, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed states.
/ CompletedNot Applicable 随机、开放、单剂量、两制剂、交叉对照设计,评价中国健康受试者在空腹及餐后状态下单次口服富马酸伏诺拉生片后的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled study to evaluate the bioequivalence of vonoprazan fumarate tablets in Chinese healthy subjects after a single oral dose in the fasting and fed state
主要目的:以浙江恒研医药科技有限公司提供的富马酸伏诺拉生片为受试制剂,按生物等效性试验的有关规定,与Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片(商品名:Vocinti®/沃克®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main objective: To use vonoprazan fumarate tablets provided by Zhejiang Hengyan Pharmaceutical Technology Co., Ltd. as the test preparation, and compare the absorption rate and extent of vonoprazan fumarate tablets (trade name: Vocinti®/Walker®, reference preparation) certified by Takeda Pharmaceutical Company Limited in healthy humans according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Hengyan Pharmaceutical Technology Co., Ltd.