A Randomized, Open-label, Parallel, Two-formulation, Single-dose Bioequivalence 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) Group R (Reference product) * Pharmacokinetics(PK) blood sample collection * Safety evaluation
• Signed the Informed Consent Form(ICF) before the study and fully understood the study content, procedures, and possible adverse reactions;
• Able to complete the study according to the protocol requirements;
• The participant or their partner has used effective contraceptive measures within 14 days before screening and promises not to have any pregnancy, sperm donation, or egg donation plans from signing the ICF until 3 months after the last dose, and voluntarily agrees to use effective non-drug contraceptive measures;
• Male and/or female participants aged ≥18 years (inclusive);
• Participant weight is not less than 50.0 kg. Body mass index (BMI) = weight (kg) / height2 (m2), with BMI in the range of 18.5-30.0 kg/m2 (inclusive);
• Confirmed to have iron deficiency anemia at screening, defined as follows (both criteria must be met): ①Hemoglobin (Hb)\<110 g/L; ②Serum transferrin saturation ≤20% and serum ferritin ≤100 ng/mL.