Actively Recruiting
A Randomized, Open-label, Two-treatment, Two-period, Two-cross-over Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2026-05-26
70
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
S
Sichuan Huiyu Pharmaceutical Co., Ltd
Lead Sponsor
S
Suzhou Guochen Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic profile and safety of two ferric carboxymaltose injections in healthy adult participants under fasting conditions. The study aims to determine if there is a significant difference between the test product provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product licensed by American Regent, Inc. (Injectafer ) in terms of iron absorption and distribution. The trial is a randomized, open-label, two-treatment, two-period, two-cross-over study involving healthy volunteers aged 18 to 55 years. Participants are randomly assigned to receive either the test product or the reference product via intravenous injection at a dose of 100 mg elemental iron (2 mL) administered continuously over 1 minute on an empty stomach after fasting for at least 10 hours. A standardized dinner is provided the night before dosing. Both groups follow the same dosing schedule and administration method. The study includes two treatment periods, and participants receive both products in a cross-over manner according to the protocol. During the study, blood samples are collected at multiple time points before and up to 96 hours after dosing to measure pharmacokinetic parameters such as peak plasma concentration and area under the curve for total iron and transferrin-bound iron in serum. Safety evaluations, including monitoring of adverse events, are conducted, especially on Day 5. The overall participation period covers screening, dosing, sample collection, and safety follow-up, with careful monitoring of vital signs, laboratory tests, and electrocardiograms to assess participant health and treatment effects.
CONDITIONS
Brief Title
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must fully understand and voluntarily agree to the study and provide written consent.
- Healthy male or female participants aged 18 to 55 years.
- Body weight of at least 50.0 kg and BMI between 19.0 and 26.0 kg/m².
- Using effective contraception for at least 14 days prior to screening and agree to continue until 3 months after last dose.
- No plans for pregnancy, sperm donation, or egg donation during the study period.
You will not qualify if you...
- History of allergies to two or more medications, iron, maltose, or related compounds; or severe asthma, eczema, or other allergic disorders.
- History or presence of iron storage diseases, iron utilization disorders, hemoglobinopathies, hemolytic anemia, severe anemia requiring transfusion, or hemodialysis.
- Iron deficiency or anemia within 6 months prior to screening.
- Significant chronic or severe diseases affecting major body systems or other unsuitable conditions.
- Acute illness within 2 weeks prior to dosing.
- Abnormal vital signs, lab tests, infectious disease tests, or ECG findings as determined by the investigator.
- History of hypersensitivity to intravenous iron.
- Recent parenteral iron, ESA therapy, or blood transfusion within specified timeframes.
- Use of medications affecting iron absorption or other medications within 2 to 4 weeks prior to screening.
- Smoking more than 5 cigarettes daily within 3 months prior or unwillingness to abstain during study.
- Recent surgeries affecting drug metabolism or planned surgeries during study.
- Participation in other clinical trials with investigational products within 3 months.
- Blood donation or significant blood loss within 3 months or platelet donation within 1 month prior.
- History of drug or alcohol abuse or unwillingness to abstain before dosing.
- Special diets or strenuous exercise affecting drug absorption within 48 hours prior to dosing.
- Recent live vaccination or planned vaccination during study.
- Inability to tolerate venipuncture or fear of needles.
- Special dietary requirements incompatible with study diet.
- Use of oral contraceptives, long-acting hormonal contraceptives within specified periods prior to screening.
- Pregnancy, breastfeeding, or positive pregnancy test at screening.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive an intravenous injection of either the test or reference ferric carboxymaltose product after fasting for at least 10 hours.
1 treatment visit (in-person) with multiple blood sample collections up to 96 hours post-dose
Duration - 5 days
Participants are monitored for safety and adverse events following treatment.
1 follow-up visit on Day 5 (in-person)
Trial Site Locations
Total: 1 location
1
Central Hospital Shandong Province
Jinan, China
Actively Recruiting
Research Team
L
Li Xiang
C
Chun Wan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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