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MechanismCysLT antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date20 Feb 1998 |
/ CompletedNot Applicable 米格列奈钙片随机、开放、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A randomized, open-label, crossover design formal bioequivalence trial of mitiglinide calcium tablets in Chinese healthy subjects
主要目的:以浙江易泽达医药科技有限公司持证的米格列奈钙片为受试制剂;并以KISSEI PHARMACEUTICAL CO., LTD.持证的米格列奈钙片为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main purpose: To evaluate the relative bioavailability and bioequivalence of mitiglinide calcium tablets in humans using the certified mitiglinide calcium tablets of Zhejiang Yizeda Pharmaceutical Technology Co., Ltd. as the test preparation and the certified mitiglinide calcium tablets of KISSEI PHARMACEUTICAL CO., LTD. as the reference preparation.
/ CompletedNot Applicable 随机、开放、单剂量、两制剂、交叉对照设计,评价空腹及餐后状态下单次口服受试制剂阿司匹林肠溶片与参比制剂阿司匹林肠溶片(商品名:Bayaspirin®/拜阿司匹灵®)在中国健康受试者中的生物等效性正式试验
[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled study was conducted to evaluate the bioequivalence of a single oral dose of the test formulation of enteric-coated aspirin tablets and the reference formulation of enteric-coated aspirin tablets (trade name: Bayaspirin®/Bayaspirin®) in healthy Chinese subjects.
主要研究目的:以浙江易泽达医药科技有限公司提供的阿司匹林肠溶片受试制剂,按生物等效性试验的有关规定,与Bayer HealthCare Manufacturing S.r.l.生产的阿司匹林肠溶片(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] The main purpose of the study is to compare the absorption rate and extent of enteric-coated aspirin tablets provided by Zhejiang Yizeda Pharmaceutical Technology Co., Ltd. with that of enteric-coated aspirin tablets (reference preparation) produced by Bayer HealthCare Manufacturing S.r.l. in healthy humans according to the relevant provisions of the bioequivalence test, and to investigate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable 随机、开放、单剂量、两制剂、交叉对照设计,评价空腹及餐后状态下单次口服受试制剂阿司匹林肠溶片与参比制剂阿司匹林肠溶片(商品名:Bayaspirin®/拜阿司匹灵®)在中国健康受试者中的生物等效性正式试验
[Translation] A formal trial of randomized, open-label, single-dose, two-formulation, crossover design to evaluate the bioequivalence of a single oral dose of the test formulation enteric-coated aspirin tablets and the reference formulation enteric-coated aspirin tablets (trade name: Bayaspirin®/Bayaspirin®) in healthy Chinese subjects under fasting and fed conditions
主要研究目的:以浙江易泽达医药科技有限公司提供的阿司匹林肠溶片受试制剂,按生物等效性试验的有关规定,与Bayer HealthCare Manufacturing S.r.l.生产的阿司匹林肠溶片(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] The main purpose of the study is to compare the absorption rate and extent of enteric-coated aspirin tablets provided by Zhejiang Yizeda Pharmaceutical Technology Co., Ltd. with that of enteric-coated aspirin tablets (reference preparation) produced by Bayer HealthCare Manufacturing S.r.l. in healthy humans according to the relevant provisions of the bioequivalence test, and to investigate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Zhejiang Yizeda Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Zhejiang Yizeda Pharmaceutical Technology Co., Ltd.
100 Deals associated with Zhejiang Yizeda Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Zhejiang Yizeda Pharmaceutical Technology Co., Ltd.