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);
Allergic constitution (e.g., asthma, eczema, etc.), or known allergy to Ferric Derisomaltose Injection or other parenteral iron preparations, maltose or its analogues, metabolites, water for injection, hydrochloric acid or sodium hydroxide, or nitrogen;
History of severe or chronic diseases of the circulatory, digestive, respiratory, urinary, hematological, metabolic, immune, or neuropsychiatric systems, or current neoplasm malignant, within 12 months prior to screening, other than iron deficiency anemia, and judged by the investigator as unsuitable for participation in the study;
Acute infection within 2 weeks prior to screening;
Laboratory tests: alanine aminotransferase (ALT) >1.5 times the upper limit of normal (×ULN); aspartate aminotransferase (AST) > 1.5×ULN; total bilirubin (TBiL) > 1.5×ULN; albumin <30 g/L; platelets <90×109/L; neutrophil count <1.3×109/L; glomerular filtration rate (GFR) <60 ml/min/1.73m2 (estimated by the simplified Modification of Diet in Renal Disease (MDRD) formula, GFR [mL/(min·1.73m2)] = 186 × serum creatinine mg/dL-1.154 × age year-0.203 (×0.742, for females)), or other results from hematology, automated urinalysis, blood chemistry, coagulation profile, iron metabolism, or serum ferritin judged by the investigator as unsuitable for participation in the study;
Parallel
Ferric Derisomaltose Injection
DrugFor the T group, participants will have a standardized dinner on the night before the trial, followed by a fasting period of at least 10 h before receiving the test product (T,10mL:1000mg \[calculated by iron\]) via intravenous infusion, diluted to 100 mL with 0.9% sodium chloride injection, and infused continuously for 30 min (±2 min).
Ferric Derisomaltose Injection [MonoFer®]
DrugFor the R group, participants will have a standardized dinner on the night before the trial, followed by a fasting period of at least 10 h before receiving the reference product (trade name: MonoFer®) (R,10mL:1000mg \[calculated by iron\]) via intravenous infusion, diluted to 100 mL with 0.9% sodium chloride injection, and infused continuously for 30 min (±2 min).
Pharmacokinetic parameter of total iron in serum: maximum observed plasma concentration (Cmax)
Cmax is the peak concentration of total iron in serum. It is directly obtained from observed blood drug concentration-time data.
Pharmacokinetic parameter of total iron in serum: area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t)
AUC0-t is the area under the concentration curve from dosing to the last measurable blood drug concentration. It is calculated using the linear trapezoidal rule.All parameters are baseline-corrected.
Pharmacokinetic parameter of transferrin bound iron in serum: Cmax
Cmax is the peak concentration of transferrin bound iron in serum. It is directly obtained from observed blood drug concentration-time data.
Pharmacokinetic parameter of transferrin bound iron in serum: AUC0-t
AUC0-t is the area under the concentration curve from dosing to the last measurable blood drug concentration. It is calculated using the linear trapezoidal rule.All parameters are baseline-corrected.
Adverse Events (AEs) and Serious Adverse Events (SAE)
Safety Assessment
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Sichuan Huiyu Pharmaceutical Co., Ltd
Lead sponsor
Suzhou Chenyan Life Science Co., Ltd.
Collaborator
Boji Data Technology (Beijing) Co., Ltd.
Collaborator
Boji Medical Technology Co., Ltd.
Collaborator
Hopeshine-Minsheng Hospital of Xinzheng
Collaborator
