[Translation] A randomized, open, parallel, two-formulation, single-dose, fasting bioequivalence pilot study of ferric carboxymaltose injection in subjects with iron deficiency anemia
主要研究目的:比较空腹给药条件下,四川汇宇海玥医药科技有限公司提供的羧基麦芽糖铁注射液(10mL:500mg(以铁计))与Vifor France持有的羧基麦芽糖铁注射液(商品名:Ferinject®,规格:10mL:500mg(以铁计))在缺铁性贫血受试者体内的药动学特征,初步评价两种制剂的生物等效性。次要研究目的:评价空腹给药条件下,四川汇宇海玥医药科技有限公司提供的羧基麦芽糖铁注射液(10mL:500mg(以铁计))的安全性。
[Translation] The main purpose of the study is to compare the pharmacokinetic characteristics of the ferric carboxymaltose injection (10mL: 500mg (in terms of iron)) provided by Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. and the ferric carboxymaltose injection (trade name: Ferinject®, specification: 10mL: 500mg (in terms of iron)) held by Vifor France in subjects with iron deficiency anemia under fasting conditions, and to preliminarily evaluate the bioequivalence of the two preparations. The secondary purpose of the study is to evaluate the safety of the ferric carboxymaltose injection (10mL: 500mg (in terms of iron)) provided by Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. under fasting conditions.