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/ Not yet recruitingNot Applicable 马来酸阿伐曲泊帕片在中国健康志愿者的人体生物等效性试验
[Translation] Human bioequivalence study of avatrombopag maleate tablets in Chinese healthy volunteers
主要目的:
研究受试制剂马来酸阿伐曲泊帕片(规格:20mg)与参比制剂马来酸阿伐曲泊帕片(Doptelet/苏可欣,规格:20mg)在健康成年受试者体内的药代动力学特征,评价口服两种制剂的生物等效性。
次要目的:
研究受试制剂马来酸阿伐曲泊帕片(规格:20 mg)和参比制剂马来酸阿伐曲泊帕片(Doptelet/苏可欣)(规格:20 mg)在健康受试者中的安全性。
[Translation] Primary objective:
To study the pharmacokinetic characteristics of the test preparation avatrombopag maleate tablets (specification: 20 mg) and the reference preparation avatrombopag maleate tablets (Doptelet/Su Kexin, specification: 20 mg) in healthy adult subjects, and to evaluate the oral bioequivalence of the two preparations.
Secondary objective:
To study the safety of the test preparation avatrombopag maleate tablets (specification: 20 mg) and the reference preparation avatrombopag maleate tablets (Doptelet/Su Kexin) (specification: 20 mg) in healthy subjects.
/ Not yet recruitingNot Applicable 马来酸阿伐曲泊帕片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Bioequivalence study of avatrombopag maleate tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:
研究空腹和餐后状态下单次口服受试制剂马来酸阿伐曲泊帕片(规格:20mg,嘉亨(珠海横琴)医药科技有限公司持证,河南福森药业有限公司生产)与参比制剂马来酸阿伐曲泊帕片(Doptelet®/苏可欣®,规格:20mg;AkaRx Inc.持证、Kawashima Plant, Eisai Co.,Ltd.生产)在健康成年受试者体内的药代动力学特征,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要目的:
研究受试制剂马来酸阿伐曲泊帕片(规格:20 mg)和参比制剂马来酸阿伐曲泊帕片(Doptelet®/苏可欣®)(规格:20 mg)在健康受试者中的安全性。
[Translation] Primary objective:
To study the pharmacokinetic characteristics of the test preparation avatrombopag maleate tablets (specification: 20 mg, licensed by Jiaheng (Zhuhai Hengqin) Pharmaceutical Technology Co., Ltd., produced by Henan Fusen Pharmaceutical Co., Ltd.) and the reference preparation avatrombopag maleate tablets (Doptelet®/Sukoxin®, specification: 20 mg; licensed by AkaRx Inc., produced by Kawashima Plant, Eisai Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary objective:
To study the safety of the test preparation avatrombopag maleate tablets (specification: 20 mg) and the reference preparation avatrombopag maleate tablets (Doptelet®/Sukoxin®) (specification: 20 mg) in healthy subjects.
/ Not yet recruitingNot Applicable 依伏卡塞片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of ivocate tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:
研究空腹和餐后状态下单次口服受试制剂依伏卡塞片(规格:1mg,上海博志研新药物研究有限公司持证,江苏利泰尔药业有限公司生产)与参比制剂依伏卡塞片(Orkedia®,规格:1mg;協和キリン株式会社生产)在健康成年受试者体内的药代动力学特征,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要目的:
研究受试制剂依伏卡塞片( 规格:1mg) 和参比制剂依伏卡塞片(Orkedia®)(规格:1mg)在健康受试者中的安全性。
[Translation] Main purpose:
The pharmacokinetic characteristics of the test preparation ivocate tablets (specification: 1 mg, licensed by Shanghai Bozhi Yanxin Drug Research Co., Ltd., produced by Jiangsu Litai Pharmaceutical Co., Ltd.) and the reference preparation ivocate tablets (Orkedia®, specification: 1 mg; produced by Kyowa Kirin Co., Ltd.) were studied in healthy adult subjects after a single oral dose in fasting and fed states, and the bioequivalence of the two preparations after oral administration in fasting and fed states was evaluated.
Secondary Purpose:
To investigate the safety of the test preparation, ivocate tablets (strength: 1 mg) and the reference preparation, ivocate tablets (Orkedia®) (strength: 1 mg) in healthy subjects.
100 Clinical Results associated with Shanghai Bozhiyan New Drug Research Co., Ltd.
0 Patents (Medical) associated with Shanghai Bozhiyan New Drug Research Co., Ltd.
100 Deals associated with Shanghai Bozhiyan New Drug Research Co., Ltd.
100 Translational Medicine associated with Shanghai Bozhiyan New Drug Research Co., Ltd.