[Translation] A randomized, open-label, parallel, two-formulation, single-dose, fasting bioequivalence trial of isomaltose iron injection in Chinese participants with iron deficiency anemia.
主要目的:比较空腹给药条件下,四川汇宇制药股份有限公司提供的异麦芽糖酐铁注射液(规格:1000 mg/10 mL)与Pharmacosmos A/S持证的异麦芽糖酐铁注射液(商品名:MonoFer®,规格:1 g/10 mL)在缺铁性贫血参与者中吸收程度和速度的差异,估算其药代动力学参数,用于计算和调整正式试验样本量,同时验证分析方法、试验流程、采血点和试验设计的合理性。
次要目的:评价空腹给药条件下,四川汇宇制药股份有限公司提供的异麦芽糖酐铁注射液(规格:1000 mg/10 mL)的安全性。
[Translation] Primary Objective: To compare the absorption rate and extent of isomaltose iron injection (1000 mg/10 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. with that of isomaltose iron injection (trade name: MonoFer®, 1 g/10 mL) certified by Pharmacosmos A/S in participants with iron deficiency anemia under fasting administration conditions, estimate their pharmacokinetic parameters, calculate and adjust the sample size for the formal trial, and validate the rationality of the analytical methods, experimental procedures, blood collection points, and experimental design.
Secondary Objective: To evaluate the safety of isomaltose iron injection (1000 mg/10 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting administration conditions.