The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition. The main questions it aims to answer are:
* \[Question 1\] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection 750 mg iron/15 mL provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength:750 mg iron/15 mL )? * \[Question 2\] Is it safe for healthy participants to take ferric carboxymaltose injection (750 mg iron/15 mL \[calculated by iron\]) 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 healthy participants 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) * PK blood sample collection * Safety evaluation
Participants must fully understand the purpose, nature, procedures, and potential adverse reactions of the study. They must voluntarily agree to participate in the trial, comply with all study requirements, and provide written informed consent before the initiation of any study procedures.
Healthy male or female participants aged 18 to 55 years (inclusive).
Participants must have a body weight of ≥ 50.0 kg; Body Mass Index(BMI) must range from 19.0 to 26.0 kg/m² (inclusive).
Participants have been using effective contraception for 14 days prior to screening. Participants must agree to use highly effective contraceptive measures from screening until 3 months after the last administration. They must have no plans for pregnancy, sperm donation, or egg donation during this period.
Participants with allergic conditions, such as a known history of hypersensitivity to two or more medications; known allergies to iron, maltose, or its analogues/ metabolites; or a history/presence of severe asthma, eczema, or other atopic allergic disorders.
History/presence of iron storage diseases (e.g., hemochromatosis), iron utilization disorders (e.g., iron-refractory iron deficiency anemia), hemoglobinopathies (e.g., thalassemia), hemolytic anemia, symptomatic anemia requiring red blood cell infusion, or undergoing hemodialysis.
History of iron deficiency or anemia within 6 months prior to screening.
History of clinically significant chronic or severe conditions affecting the respiratory, cardiovascular, gastrointestinal, renal, hematological, lymphatic, endocrine, immune, psychiatric, or nervous systems; past or current diagnosis of porphyria cutanea tarda; or other conditions deemed by the investigator to be unsuitable for participation.
Parallel
Ferric Carboxymaltose 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, 2 mL: 100 mg elemental iron) via intravenous injection in the single upper limb, at a continuous rate for 1 min, with a speed of 2 mL/min.
Ferric Carboxymaltose Injection [Injectafer®]
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: Injectafer®) (R, 2 mL: 100 mg elemental iron) via intravenous injection on an empty stomach, at a continuous rate for 1 min, with a speed of 2 mL/min.
Pharmacokinetic parameter of total iron in serum: Peak 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 versus time curve (AUC）
AUC is the area under the concentration curve from dosing to the last measurable blood drug concentration. It is calculated using the linear trapezoidal rule.
Pharmacokinetic parameter of transferrin bound iron in serum: Cmax
Cmax is the peak concentration of transferrin iron in serum. It is directly obtained from observed blood drug concentration-time data.
Pharmacokinetic parameter of transferrin bound iron in serum: AUC
AUC is the area under the concentration curve from dosing to the last measurable blood drug concentration. It is calculated using the linear trapezoidal rule.
Adverse Events (AEs) and Serious Adverse Events (SAE)
Safety Assessment
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Sichuan Huiyu Pharmaceutical Co., Ltd
Lead sponsor
Suzhou Guochen Biotechnology Co., Ltd.
Collaborator
Guangzhou Jeeyor Medical Research Co.,Ltd.
Collaborator
Boji Medical Technology Co., Ltd.
Collaborator
Jinan Central Hospital
Collaborator
