[Translation] Randomized, open-label, parallel, two-preparation, single-dose, fasting state bioequivalence trial of iron carboxymaltose injection in subjects with iron deficiency anemia
主要研究目的:比较空腹给药条件下,四川汇宇制药股份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,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,四川汇宇制药股份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] Main research purpose: To compare the iron carboxymaltose injection (10mL: 500mg (calculated as iron)) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the iron carboxymaltose injection held by Vifor France (trade name: Pharmacokinetic characteristics of Ferinject®, strength: 10mL: 500mg (calculated as iron) in subjects with iron deficiency anemia, to evaluate the bioequivalence of the two preparations. Secondary research purpose: To evaluate the safety of iron carboxymaltose injection (10 mL: 500 mg (calculated as iron)) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting administration conditions.