An Open label, Multicenter, Randomized, Single-dose, Parallel, two-treatment, Bioequivalence study of Ferric Carboxymaltose Injection 750 mg/15mL (50 mg/mL) of RK Pharma Inc. with INJECTAFER (Ferric Carboxymaltose Injection 750 mg/15 mL [50mg/mL]) of American Regent, Inc. Shirley, NY 11967, following a single intravenous dose of 750mg in adult human patients with iron deficiency anemia

RK Pharma Inc7 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年10月29日最近更新: 2025年12月27日

试验速览

阶段: 1 期
状态: 尚未招募
发起方: RK Pharma Inc
入组人数: 80
试验地点: 7
主要终点: 1)To determine the bioequivalence for Ferric Carboxymaltose Injection 750 mg/15mL (50

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open label, multicenter, randomized, single-dose, parallel, two treatment, single-period, bioequivalence study. Patients who meet the inclusion and exclusion criteria will undergo safety assessments within 21 days prior to the administration of the investigational medicinal product .All eligible patients, enrolled in the study, will be housed for at least 24.00 hours prior to drug administration and up to 72.00 hours post dose. After an overnight fast for at least 10.00 hours, as per randomization schedule, patients will be administered undiluted study drug Ferric Carboxymaltose Injection 750 mg/15mL (50mg/mL) of RK Pharma Inc. or INJECTAFER® (Ferric Carboxymaltose Injection 750mg/15mL [50 mg/mL]) of American Regent, Inc). The minimum duration of this study will be at least 07 days. Safety may be assessed by the monitoring of adverse clinical events, electrocardiograms, clinical laboratory evaluations, and physical examinations.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Patient or LAR willing to provide informed consent to participate.
•Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/not appropriate or with non-dialysis dependent chronic renal disease (as defined by either i)GFR is less than 60ml/min/1.73m2 on screening (As calculated by MDRD), or ii)GFR is lessthan90ml/min/1.73m2 during screening and at least 1 marker of kidney damage based on medical history within 3 months of screening.
•Markers of kidney disease may include: albuminuria (ACR less than 3mg/mmol), hematuria, and electrolyte abnormalities due to tubular disorders, renal histological abnormalities, structural abnormalities detected by imaging or a history of kidney transplantation.
•Patients considered to be suitable for treatment with Ferric Carboxymaltose Injection based on Investigator judgement.
•Patients with body weight more than or equals to 50 kg at screening and check in, with BMI of 18.50 to 30.00 kg/m2 at the time of screening.
•Patients with hemoglobin levels of more than or equals to 9.0 g/dL and less than 12g/dL at screening.
•Patients with Iron status evaluation at screening defined as: Serum Ferritin of less than or equals to 100 ng/mL (or less than or equal to 300ng/mL when TSAT is less than or equal to 30%).
•Patients with normal Serum Phosphate level 3.4 to 4.5 mg/dl (1.12 to 1.45 mmol/L).
•Patients with adequate hematopoietic and liver function at screening, defined as iii)ANC more than or equal to 1500/mm3, Platelet count more than or equal to 100,000/mm
•iv)AST and ALT less than or equal to 3 times ULN, Alkaline phosphatase leass than or equal to 2.5 times ULN, Bilirubin less than or equal to 1.5 times ULN.
•Patient agrees to comply with the study procedures and requirements of the study.
•Male Patients willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, vasectomized.
•Subjects should not donate sperm during this time.
•Female patients should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral tubal ligation, bilateral oophorectomy; or practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing in case of women with a childbearing potential and prepared to continue for at least 30 days following the last treatment.
•Each female study participant should be negative serum pregnancy test at screening and urine pregnancy test in check-in.

排除标准

•Patients with known hypersensitivity to ferric carboxymaltose, or any of its inactive components, excipients, or similar product or any other iron preparation.
•Patients who have received any of the following medications in recent past: v)Parenteral iron therapy within the last 6 months prior to randomization.
•vi)Oral iron therapy within 4 weeks prior to randomization.
•Erythropoiesis stimulating agents within 3 months prior to randomization.
•vii)Concomitant medications that may affect the PK results based on investigators discretion.
•Patients with clinically significant uncontrolled blood pressure or labile hypertension (systolic blood pressure more than 150 mm/Hg and diastolic blood pressure more than 100 mm/Hg. 4) Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR less than 15 mL/min/1.73 m2] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period 5) Patients considered to be anemic due to other aetiology such as severe malabsorption syndrome, immunosuppressant use, aplastic anemia, megaloblastic or haemolytic anaemia, untreated Vitamin B12 or folate deficiency or hemoglobinopathy etc.
•Patients with hemochromatosis or other iron storage disorders.
•Patients with blood loss leading to hemodynamic instability.
•Patients who had major surgery or invasive intervention within 4 weeks prior to screening, organ transplant within 6 months prior to screening, or have a surgery or intervention planned during the course of the study.
•Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
•Patients who have HIV or positive hepatitis screen including hepatitis B surface antigen, HCV antibodies and RPR.
•Patients with positive urine alcohol test and drugs of abuse in urine during screening and at check-in.
•Patients with clinically significant abnormal blood pressure (Systolic blood pressure below 100 mm/Hg and above 150 mm/Hg; Diastolic blood pressure below 60 mm/Hg and above 100 mm/Hg).
•Patients who participated in another clinical trial within 60 days prior to randomization.
•Patients with known active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).
•Patients with significant comorbidities such as congestive heart failure, asthma, decompensated liver cirrhosis, eczema or atopic allergy, acute/chronic infection of any type, systemic lupus erythematous, rheumatoid or inflammatory arthritis, inflammatory bowel disease, rheumatic disease or any other condition, that in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
•Female patients who are pregnant or planning (women with childbearing potential) to become pregnant during the study.