BioequivalencyPhase 1NCT06674486
Bioequivalence Study of Iron Sucrose Injection in Healthy Participants
A Phase 1 study testing Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) in people with Bioequivalency and Safety Issues, 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 single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these two injections in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalency, Safety Issues
- What is being tested?
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2024to 14 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, males or females;
- Body weight ≥ 50.0 kg (male subjects) or ≥ 45.0 kg (female subjects), and body mass index (BMI) within 19-26 kg/m2 (both inclusive);
- Subjects voluntarily sign a written informed consent form.
Who cannot join
- Those who have a history of or currently have clinically serious diseases, including circulatory, endocrine, nervous, digestive, and respiratory, hematology, immunology, psychiatry and metabolic disorders or abnormalities or any other diseases that can interfere with the study results (e.g., non-iron deficiency anemia, history of severe asthma, hepatic or renal insufficiency);
- Those with a history of iron deficiency or anemia within 6 months prior to the initial administration of the investigational drug;
- Those with a history of allergy to two or more drugs (or foods), or allergy to iron, sucrose, or iron products;
- Those who have undergone surgery within 28 days prior to the initial administration of the investigational drug, or who plan to undergo surgery during the study period;
- Those who have been vaccinated within 28 days prior to the initial administration of the investigational drug, or who plan to be vaccinated during the study period;
- Those who have received any medications or supplements (including herbal remedies) within 14 days prior to the initial administration of investigational drug;
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- Those who have used any iron supplements or iron-containing herbs or nutritional supplements within 3 months prior to the initial administration of the investigational drug;
- Those who have used any drugs that inhibit or induce hepatic drug metabolism (e.g., inducers-barbiturates, carbamazepine, phenytoin and rifampicin; inhibitors-SSRIs, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole-containing antifungals and HIV protease inhibitors) within 30 days prior to the initial administration of the investigational drug;
- Those who have used any investigational medicinal product or been enrolled in any clinical studies of drugs/medical devices within 3 months prior to the initial administration of the investigational drug;
- Those who have donated blood or had a blood loss volume of >400 mL within 3 months before the initial administration of the investigational drug;
- Those who cannot tolerate venipuncture and/or have a history of hemophobia/fear of needles;
- Those who have used oral contraceptives within 30 days before the initial administration of the investigational drug, or who have received long-acting estrogens or progesterone injections or implants within 6 months before the initial administration of the investigational drug;
- Those (females) who have had unprotected sex within 14 days prior to the initial administration of the investigational drug, or females who are pregnant or breastfeeding;
- Subjects and their partners who cannot take at least one non-medication contraceptive measures from signing the ICF to 3 months after the last administration, or those who plan to bear a child, or donate egg or sperm during this period;
- Those who have special dietary requirements and are unable to comply with a uniform diet or have dysphagia;
- Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup=250 mL) every day within 3 months prior to the initial administration of the investigational drug;
- Those who have consumed or plan to consume any caffeine-containing foods/beverages (e.g., coffee, strong tea, chocolate) or foods (e.g., sardines, animal livers)/beverages that are rich in xanthine in the 48 h prior to the initial administration of the investigational drug;
- Those who have consumed or plan to consume grapefruits or grapefruit-related citrus fruits (e.g., bigarades and pomelos), carambola, pawpaws and pomegranate, those who refuse to discontinue such diet during the study, or those who had strenuous exercises within 7 days prior to the initial administration of the investigational drug;
- Those who are addicted to smoking or who have smoked no less than 5 cigarettes per day within 3 months prior to the initial administration of the investigational drug;
- Those who are addicted to alcohol or who have frequently consumed alcohol, namely, consumed more than 14 units of alcohol every week (1 unit ≈ 200 mL of beer containing 5% alcohol, 25 mL of liquor containing 40% alcohol, or 85 mL of wine containing 12% alcohol) within 6 months prior to the initial administration of the investigational drug;
- Those who abuse drugs or have used soft drugs (such as cannabis) within 3 months prior to the initial administration of the investigational drug, or have used hard drugs (such as morphine, methamphetamine, ketamine, THC, MDMA) within 1 year prior to the first use of the investigational drug;
- Those with clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram, or laboratory tests as determined by the investigator, and those judged by the investigator to have increased safety risks if they continue to participate in the study;
- Those who fail the alcohol test or are positive in the drug abuse screening upon admission;
- Those who are unable to participate in the study due to their own reasons;
- Those who are deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bio-equivalence Study of Iron Sucrose Injection in Healthy Participants
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these two injections in healthy subjects. The main questions it aims to answer are:
[Question 1] Is there significant difference in the pharmacokinetic profile between the Iron Sucrose Injection (100 mg/5 mL [calculated by iron]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the Iron Sucrose Injection (trade name: Venofer®, 100 mg/5 mL [calculated by iron]) held by Vifor France? [Question 2] Is it safe for the healthy subjects to take the test product (100 mg/5 mL [calculated by iron]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product held by Vifor France? Participants will be randomly divided into group I and group II, with equal number of subjects in each group. Each subject will receive only one dose of either the test product or the reference product in each period (two-sequence crossover study).
- Conditions
- Bioequivalency, Safety Issues
- Being tested
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer), Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer)Drug
For the Group I, participants will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd). After a washout period, subjects will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by Vifor France).
Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)Drug
For the Group II, participants will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by Vifor France) . After a washout period, subjects will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd).
| Study group | Role | What they receive |
|---|---|---|
| Group I - Receive test product first and then reference product | Experimental | Not described Receives: Drug: Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer) |
| Group II - Receive reference product first and then test product | Experimental | Not described Receives: Drug: Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of total iron and transferrin-bound iron: Cmax
Cmax is the maximum observed concentration of total iron and transferrin-bound iron.
Measured: 36 hours, 24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, and 36 hours
Pharmacokinetic parameter of total iron and transferrin-bound iron: AUC0-t
AUC0-t is the area under the plasma concentration-time curve from time zero to time point t for the last measurable concentration of total iron and transferrin-bound iron.
Measured: 36 hours, 24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, and 36 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start22 Nov 2024
- Primary completion18 Dec 2024
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalencyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan (Zhengzhou) Zhonghui Cardiovascular Hospital, Changsha Duxact Biotechnology Co., Ltd, Suzhou Guochen Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674486
- Sponsor's protocol ID
- DUXACT-2409005
- Status last verified
- Mar 2025
- First submitted
- 4 Nov 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bio-equivalence Study of Iron Sucrose Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT06674486
- Acronym / sponsor ID
- DUXACT-2409005
- Conditions
- Bioequivalency, Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Henan (Zhengzhou) Zhonghui Cardiovascular Hospital, Changsha Duxact Biotechnology Co., Ltd, Suzhou Guochen Biotechnology Co., Ltd.
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 5 Nov 2024 (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 single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these two injections in healthy subjects. The main questions it aims to answer are:
[Question 1] Is there significant difference in the pharmacokinetic profile between the Iron Sucrose Injection (100 mg/5 mL [calculated by iron]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the Iron Sucrose Injection (trade name: Venofer®, 100 mg/5 mL [calculated by iron]) held by Vifor France? [Question 2] Is it safe for the healthy subjects to take the test product (100 mg/5 mL [calculated by iron]) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. and the reference product held by Vifor France? Participants will be randomly divided into group I and group II, with equal number of subjects in each group. Each subject will receive only one dose of either the test product or the reference product in each period (two-sequence crossover study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Receive test product first and then reference product | Experimental | Drug: Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer) |
| Group II - Receive reference product first and then test product | Experimental | Drug: Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years, males or females;
- Body weight ≥ 50.0 kg (male subjects) or ≥ 45.0 kg (female subjects), and body mass index (BMI) within 19-26 kg/m2 (both inclusive);
- Subjects voluntarily sign a written informed consent form.
Key exclusion criteria (25 listed)
- Those who have a history of or currently have clinically serious diseases, including circulatory, endocrine, nervous, digestive, and respiratory, hematology, immunology, psychiatry and metabolic disorders or abnormalities or any other diseases that can interfere with the study results (e.g., non-iron deficiency anemia, history of severe asthma, hepatic or renal insufficiency);
- Those with a history of iron deficiency or anemia within 6 months prior to the initial administration of the investigational drug;
- Those with a history of allergy to two or more drugs (or foods), or allergy to iron, sucrose, or iron products;
- Those who have undergone surgery within 28 days prior to the initial administration of the investigational drug, or who plan to undergo surgery during the study period;
- Those who have been vaccinated within 28 days prior to the initial administration of the investigational drug, or who plan to be vaccinated during the study period;
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 |
|---|---|---|
| Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer)For the Group I, participants will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd). After a washout period, subjects will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by Vifor France). | Drug | Group I - Receive test product first and then reference product |
| Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)For the Group II, participants will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by Vifor France) . After a washout period, subjects will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd). | Drug | Group II - Receive reference product first and then test product |
Primary outcome
Pharmacokinetic parameter of total iron and transferrin-bound iron: Cmax
Time frame: 36 hours, 24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, and 36 hours
Cmax is the maximum observed concentration of total iron and transferrin-bound iron.
Pharmacokinetic parameter of total iron and transferrin-bound iron: AUC0-t
Time frame: 36 hours, 24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, and 36 hours.
AUC0-t is the area under the plasma concentration-time curve from time zero to time point t for the last measurable concentration of total iron and transferrin-bound iron.
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 24 Mar 2025.
- Individual participant dataSharing planned: No
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 Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) in people with Bioequivalency and Safety Issues, 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 3 inclusion and 25 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 24 Mar 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 and transferrin-bound iron: Cmax (time frame: 36 hours, 24 hours, 12 hours and 0 hour before administration, 2, 6, 8, 10, 15, 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12, 14, 24, and 36 hours). 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 24 Mar 2025.