A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions

The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anemia under fasting condition. The main questions it aims to answer are: * \[Question 1\] Is there significant difference in the pharmacokinetic profile between the ferric derisomaltose injection 10mL:1000mg \[calculated by iron\]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric derisomaltose injection held by Pharmacosmos A/S . (trade name: MonoFer®, strength: 10mL:1000mg \[calculated by iron\]) )? * \[Question 2\] Is it safe for participants with iron deficiency anemia to take ferric derisomaltose injection (10mL:1000mg \[calculated by iron\])) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of participants with iron deficiency anemia in each group, to receive test product or reference product according to the protocol below. * Dosing on D1: Group T (Test product)…

• Pharmacokinetic parameter of total iron in serum: maximum observed plasma concentration (Cmax)
• Pharmacokinetic parameter of total iron in serum: area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)
• Pharmacokinetic parameter of transferrin bound iron in serum: Cmax
• Pharmacokinetic parameter of transferrin bound iron in serum: AUC0-t

1. Study completion

   Nov 1, 2026

2. Last registry update

   Oct 13, 2026

3. Primary completion

   Sep 29, 2026

4. Registered

   Aug 27, 2026

5. Started

   Jul 23, 2026