Healthy AdultPhase 1NCT06895993
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants
A Phase 1 study testing Ferric Carboxymaltose Injection and Ferric Carboxymaltose Injection [Injectafer®] in people with Healthy Adult, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Ferric Carboxymaltose Injection and Ferric Carboxymaltose Injection [Injectafer®]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to 8 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 60 years (inclusive).
- 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).
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Phase I clinical trial unit of the First Hospital of Jilin University
Changchun, Jilin, 130000
About this study
Official title: 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:
- [Question 1] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection (100 mg iron/2 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength: 100 mg iron/2 mL)?
- [Question 2] Is it safe for healthy participants to take ferric carboxymaltose injection (10 mL: 500 mg [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
- Conditions
- Healthy Adult
- Being tested
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Injectafer®]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose InjectionDrug
For 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®]Drug
For 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.
| Study group | Role | What they receive |
|---|---|---|
| Test product-Ferric carboxymaltose Injection provided by SichuanHuiyuPharma | Experimental | Not described Receives: Drug: Ferric Carboxymaltose Injection |
| Reference product- licensed by American Regent, Inc. | Active comparator | Not described Receives: Drug: Ferric Carboxymaltose Injection [Injectafer®] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of total iron in serum: Cmax、AUC
Cmax is the peak concentration of total iron in serum. It is directly obtained from observed blood drug concentration-time data. 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.
Measured: 36 hours, 24 hours, and 12 hours before administration; 0 hours and at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours post-dose
Pharmacokinetic parameter of transferrin bound iron in serum: Cmax、AUC
Cmax is the peak concentration of transferrin iron in serum. It is directly obtained from observed blood drug concentration-time data. 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.
Measured: 36 hours, 24 hours, and 12 hours before administration; 0 hours and at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours post-dose
Secondary outcomes (1)
Adverse Events (AEs) and Serious Adverse Events (SAE)
Safety Assessment
Measured: On Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start7 Apr 2025
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Sichuan Huiyu Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Guochen Biotechnology Co., Ltd., Guangzhou Jeeyor Medical Research Co.,Ltd., Boji Medical Technology Co., Ltd., The First Hospital of Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895993
- Sponsor's protocol ID
- 2024BE-SJMYTT
- Status last verified
- May 2025
- First submitted
- 20 Mar 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel, Two-treatment, Single Dose Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06895993
- Acronym / sponsor ID
- 2024BE-SJMYTT
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Suzhou Guochen Biotechnology Co., Ltd., Guangzhou Jeeyor Medical Research Co.,Ltd., Boji Medical Technology Co., Ltd., The First Hospital of Jilin University
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (100 mg iron/2 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength: 100 mg iron/2 mL)?
- [Question 2] Is it safe for healthy participants to take ferric carboxymaltose injection (10 mL: 500 mg [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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product-Ferric carboxymaltose Injection provided by SichuanHuiyuPharma | Experimental | Drug: Ferric Carboxymaltose Injection |
| Reference product- licensed by American Regent, Inc. | Active comparator | Drug: Ferric Carboxymaltose Injection [Injectafer®] |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 60 years (inclusive).
- 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).
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose InjectionFor 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. | Drug | Test product-Ferric carboxymaltose Injection provided by SichuanHuiyuPharma |
| Ferric Carboxymaltose Injection [Injectafer®]For 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. | Drug | Reference product- licensed by American Regent, Inc. |
Primary outcome
Pharmacokinetic parameter of total iron in serum: Cmax、AUC
Time frame: 36 hours, 24 hours, and 12 hours before administration; 0 hours and at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours post-dose
Cmax is the peak concentration of total iron in serum. It is directly obtained from observed blood drug concentration-time data. 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、AUC
Time frame: 36 hours, 24 hours, and 12 hours before administration; 0 hours and at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours post-dose
Cmax is the peak concentration of transferrin iron in serum. It is directly obtained from observed blood drug concentration-time data. 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.
1 secondary outcome
Adverse Events (AEs) and Serious Adverse Events (SAE)
Time frame: On Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferric Carboxymaltose Injection and Ferric Carboxymaltose Injection [Injectafer®] in people with Healthy Adult, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter of total iron in serum: Cmax、AUC (time frame: 36 hours, 24 hours, and 12 hours before administration; 0 hours and at 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.