四川汇宇制药异麦芽糖酐铁注射液启动生物等效性试验 适应症为缺铁性贫血

Group 1 - The clinical trial for Sichuan Huiyu Pharmaceutical Co., Ltd.'s Isomaltosyl Iron Injection has been initiated, focusing on its bioequivalence in participants with iron deficiency anemia [1] - The trial is registered under CTR20260095, with the first public information date set for January 9, 2026 [1] - The primary objective is to compare the absorption levels and rates of the company's Isomaltosyl Iron Injection with that of Pharmacosmos A/S in a fasting state [1] Group 2 - The trial is currently ongoing and has not yet recruited participants, with a target enrollment of 24 individuals [2] - The drug is indicated for iron deficiency anemia, which is characterized by symptoms such as fatigue and dizziness due to insufficient iron intake or absorption [1] - Key endpoints of the trial include Cmax, AUC0-t, and AUC0-∞, with secondary endpoints including Tmax, λz, t1/2, and AUC_%Extrap [1]