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Official title Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
ClinicalTrials.gov ID: NCT07606105
What this study is testing
What is Ferric Carboxymaltose Injection?
Ferric Carboxymaltose Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 750 mg iron/15 mL provided by Sichuan Huiyu Pharmaceutical Co., Ltd.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Participants must fully understand the purpose, nature, procedures, and potential adverse reactions of the study. They must voluntarily agree to...
- Healthy male or female participants aged 18 to 55 years (inclusive).
- Participants must have a body weight of ≥ 50.0 kg; Body Mass Index(BMI) must range from 19.0 to 26.0 kg/m² (inclusive).
- Participants have been using effective contraception for 14 days prior to screening. Participants must agree to use highly effective contraceptive...
You likely can't join if
- Participants with allergic conditions, such as a known history of hypersensitivity to two or more medications; known allergies to iron, maltose, or...
- History/presence of iron storage diseases (e.g., hemochromatosis), iron utilization disorders (e.g., iron-refractory iron deficiency anemia)...
- History of iron deficiency or anemia within 6 months prior to screening.
- History of clinically significant chronic or severe conditions affecting the respiratory, cardiovascular, gastrointestinal, renal, hematological...
- Acute conditions (e.g., acute infection, acute gastrointestinal disorders such as nausea, vomiting, diarrhea, or constipation, etc.) within 2 weeks...
- Participants with clinically significant abnormalities in vital signs, physical examination, laboratory tests (e.g., hematology, urinalysis, blood...
See the full eligibility criteria
Who can 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...
- Healthy male or female participants aged 18 to 55 years (inclusive).
- Participants must have a body weight of ≥ 50.0 kg; Body Mass Index(BMI) must range from 19.0 to 26.0 kg/m² (inclusive).
- Participants have been using effective contraception for 14 days prior to screening. Participants must agree to use highly effective contraceptive measures from screening until 3 months after the last administration...
What rules you out
- Participants with allergic conditions, such as a known history of hypersensitivity to two or more medications; known allergies to iron, maltose, or its analogues/ metabolites; or a history/presence of severe asthma...
- History/presence of iron storage diseases (e.g., hemochromatosis), iron utilization disorders (e.g., iron-refractory iron deficiency anemia), hemoglobinopathies (e.g., thalassemia), hemolytic anemia, symptomatic anemia...
- History of iron deficiency or anemia within 6 months prior to screening.
- History of clinically significant chronic or severe conditions affecting the respiratory, cardiovascular, gastrointestinal, renal, hematological, lymphatic, endocrine, immune, psychiatric, or nervous systems; past or...
- Acute conditions (e.g., acute infection, acute gastrointestinal disorders such as nausea, vomiting, diarrhea, or constipation, etc.) within 2 weeks prior to the first dose.
- Participants with clinically significant abnormalities in vital signs, physical examination, laboratory tests (e.g., hematology, urinalysis, blood chemistry, coagulation function tests, iron metabolism assessments)...
- History of hypersensitivity or intolerance to intravenous iron administration.
- Receiving parenteral iron treatment within 6 months prior to screening, erythropoiesis-stimulating agent (ESA) therapy and/or blood transfusion within 4 weeks prior to screening.
- Use of any medication that may affect iron absorption iron absorption within 28 days prior to dosing, such as antacids (e.g., omeprazole), tetracycline antibiotics, calcium supplements, or lipid-lowering agents (e.g...
- 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 from 48 hours prior to dosing until the completion of blood sampling in each...
- 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 or devices within 3 months prior to screening.
- Blood donation or significant blood loss due to other reasons within 3 months prior to screening (\> 400 mL, excluding menstrual blood loss in female participants), or donated platelets in an amount equal to or...
- 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 screening result.
- Participants with history of alcohol abuse within 1 year prior to screening, defined as average daily alcohol consume over 2 units (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine), or are unwilling...
- Participants who have special diet: xanthine-rich foods (e.g., coffee, chocolate, tea or cocoa beverages), iron-rich foods including animal organs, animal blood, spinach, as well as calcium/phosphorus-rich seafood...
- Participants who 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.
- Any other condition deemed by the investigator to be unsuitable for enrollment. 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.
- Pregnancy, breastfeeding, or positive pregnancy test at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.