A Randomized, Open-label, Parallel, Two-treatment, Single Dose Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
A Randomized, Open-label, Parallel, Two-treatment, Single Dose Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
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:
Inclusion Criteria:
Exclusion Criteria:
Participants with allergic conditions, such as a known history of hypersensitivity to two or more medications; known allergies to iron, maltose, or its analogues and metabolites; or a history/presence of dermatological conditions (e.g., eczema).
History of iron storage diseases (e.g., hemochromatosis), iron utilization disorders (e.g., iron-refractory iron deficiency anemia), hemoglobinopathies (e.g., thalassemia), or symptomatic anemia requiring red blood cell infusion.
History of clinically significant acute or chronic, or severe conditions affecting the respiratory, cardiovascular, gastrointestinal, renal, hematological, lymphatic, endocrine, immune, psychiatric, or nervous systems within 12 months prior to screening.
Acute infection within 2 weeks prior to screening.
Participants with clinically significant abnormalities in vital signs, physical examination, laboratory tests (e.g., hematology, urinalysis, blood chemistry, coagulation function tests, iron metabolism assessments), infectious disease examination, or 12-lead electrocardiogram (ECG), as determined by the investigator; or calcium and phosphorus values in blood chemistry tests are in the abnormal range.
Serious arrhythmias shown in ECG at screening, such as recurrent or symptomatic ventricular tachycardia, atrial fibrillation accompanied by rapid ventricular response, or supraventricular tachycardia, and not suitable for the trial at the investigator's discretion.
History of hypersensitivity or intolerance to intravenous iron administration.
Receiving intravenous iron treatment within 3 months prior to screening, erythropoiesis-stimulating agent (ESA) therapy and/or blood transfusion within 4 weeks prior to screening, and oral iron or iron-containing products within 7 days prior to screening.
Use of any medications (prescription, over-the-counter, herbal remedies, or dietary supplements) and healthcare products within 2 weeks prior to screening.
History of smoking an average of more than 5 cigarettes per day within 3 months prior to screening or unwillingness to abstain from smoking during the study.
Participants who have undergone surgeries within 6 months prior to screening that might affect drug absorption, distribution, metabolism and excretion, or planning to undergo surgeries during the study.
Participants who have enrolled in other clinical trials and received investigational products within 3 months prior to screening.
Blood donation within 3 months prior to screening; blood donation or significant blood loss due to other reasons within 6 months prior to screening (> 400 mL, excluding menstrual blood loss in female participants), or plan to donate blood during the study.
Participants with drug abuse history (including the use of various anesthetic and psychotropic drugs for non-medical purposes) within 1 year prior to screening or have a positive drug abuse test result.
Participants with history of alcohol abuse within 1 year prior to screening, defined as average weekly alcohol consume over 2 units (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine), or are unwilling to abstain from alcohol or alcohol-containing products during the study, or have positive breath alcohol test result.
Participants who have chocolate, caffeine-containing or xanthine-rich foods or beverages, or specific foods (e.g., animal liver, animal blood, spinach, dragon fruit, mango, grapefruit or grapefruit-containing products), or taking strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion, within 48 hours before receiving the investigational product.
Participants who have received a live vaccine within 14 days prior to screening, or plan to receive vaccination during the study.
Inability to tolerate venipuncture or history of fear of needles or hemophobia.
Participants with special dietary requirements, and participants who cannot accept the study standardized diet.
Participants who have acute illness or receive concomitant medications between screening and investigational product administration.
Participants not suitable for the trial at the investigator's discretion.
In addition to the aforementioned requirements, females who meet the following conditions should also be excluded:
Use of oral contraceptives within 30 days prior to screening.
Use of long-acting estrogen or progestin injections (progestin-based intrauterine devices), or implants within 6 months prior to screening.
Unprotected sexual intercourse with a partner within 14 days prior to screening.
Pregnancy, breastfeeding, or positive pregnancy test at screening.