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羧基麦芽糖铁注射液在中国缺铁性贫血成年受试者中的一项随机、开放、空腹、单剂量、平行生物等效性研究
[Translation] A randomized, open-label, fasting, single-dose, parallel bioequivalence study of iron carboxymaltose injection in Chinese adult subjects with iron deficiency anemia
主要研究目的:考察空腹状态下单次静脉推注给予受试制剂羧基麦芽糖铁注射液(规格:按Fe计10mL:500mg,赣江新区博瑞创新医药有限公司提供)与参比制剂羧基麦芽糖铁注射液(商品名:Ferinject®,规格:按Fe计10mL:500mg,Vifor France持证生产)在中国缺铁性贫血受试者体内的相对生物利用度,分析两种制剂的药代动力学参数,评价空腹状态静脉推注两种制剂的生物等效性,为该药的申报及临床用药提供参考依据。 次要研究目的:评价受试制剂和参比制剂空腹状态下单次静脉推注给药500mg后在中国缺铁性贫血受试者中的安全性。
[Translation] Main research purpose: To investigate the single intravenous bolus administration of the test preparation Ferric Carboxymaltose Injection (specification: 10mL:500mg based on Fe, provided by Ganjiang New District Borui Innovation Pharmaceutical Co., Ltd.) and the reference preparation Ferric Carboxymaltose under fasting conditions Relative bioavailability of injection (trade name: Ferinject®, specification: 10mL:500mg based on Fe, produced by Vifor France with a license) in Chinese subjects with iron deficiency anemia, and analyze the pharmacokinetic parameters of the two preparations , to evaluate the bioequivalence of two preparations injected intravenously in the fasting state, and to provide a reference basis for the application and clinical use of this drug. Secondary study purpose: To evaluate the safety of the test preparation and reference preparation in Chinese subjects with iron deficiency anemia after a single intravenous bolus administration of 500 mg in the fasting state.
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