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Search / Trial NCT06895993

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants

Launched by SICHUAN HUIYU PHARMACEUTICAL CO., LTD · Mar 25, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 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.
  • 2. Healthy male or female participants aged 18 to 60 years (inclusive).
  • 3. Male participants must have a body weight of ≥ 50.0 kg. Female participants must have a body weight of ≥ 45.0 kg. BMI must range from 19.0 to 26.0 kg/m² (inclusive).
  • 4. 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.
  • Exclusion Criteria:
  • 1. 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).
  • 2. 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.
  • 3. 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.
  • 4. Acute infection within 2 weeks prior to screening.
  • 5. 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.
  • 6. 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.
  • 7. History of hypersensitivity or intolerance to intravenous iron administration.
  • 8. 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.
  • 9. Use of any medications (prescription, over-the-counter, herbal remedies, or dietary supplements) and healthcare products within 2 weeks prior to screening.
  • 10. 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.
  • 11. 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.
  • 12. Participants who have enrolled in other clinical trials and received investigational products within 3 months prior to screening.
  • 13. 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.
  • 14. 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.
  • 15. 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.
  • 16. 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.
  • 17. Participants who have received a live vaccine within 14 days prior to screening, or plan to receive vaccination during the study.
  • 18. Inability to tolerate venipuncture or history of fear of needles or hemophobia.
  • 19. Participants with special dietary requirements, and participants who cannot accept the study standardized diet.
  • 20. Participants who have acute illness or receive concomitant medications between screening and investigational product administration.
  • 21. 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:
  • 22. Use of oral contraceptives within 30 days prior to screening.
  • 23. Use of long-acting estrogen or progestin injections (progestin-based intrauterine devices), or implants within 6 months prior to screening.
  • 24. Unprotected sexual intercourse with a partner within 14 days prior to screening.
  • 25. Pregnancy, breastfeeding, or positive pregnancy test at screening.

About Sichuan Huiyu Pharmaceutical Co., Ltd

Sichuan Huiyu Pharmaceutical Co., Ltd. is a leading biopharmaceutical company based in China, dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong emphasis on quality and efficacy, the company specializes in a diverse portfolio of pharmaceutical products, including those targeting chronic diseases and critical medical conditions. Sichuan Huiyu is committed to advancing healthcare through its robust clinical trial programs, leveraging cutting-edge technology and a team of experienced professionals to ensure the highest standards of safety and compliance. The company's mission is to enhance patient outcomes and contribute to the global pharmaceutical landscape through its scientific expertise and collaborative partnerships.

Locations

Changchun, Jilin, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported