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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 ferric 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] The main purpose of the study is to investigate the relative bioavailability 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 injection (trade name: Ferinject®, specification: 10mL:500mg based on Fe, produced with Vifor France) in Chinese subjects with iron deficiency anemia after a single intravenous push in the fasting state, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations in the fasting state, and provide a reference for the application and clinical use of the drug. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese subjects with iron deficiency anemia after a single intravenous push of 500mg in the fasting state.
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