CTRI/2022/03/041253已完成不适用
A multicenter, randomized, single-dose, parallel, two-treatment, bioequivalence study of Ferric Carboxymaltose Injection 1000 mg Iron /20mL (50 mg/mL) of RK Pharma Inc. with Ferinject® ɛisencarboxymaltose 50 mg Eisen/ml, Injektions- und Infusionslösung, 1 Durchstechflasche (20 ml) 20 ml equals to 1000 mg, Pharmazeutischer Unternehmer: Vifor France, 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, Frankreich, Mitvertreiber: Vifor Pharma Deutschland GmbH, Baierbrunner Straße 29, 81379 München, Deutschland following a single intravenous dose of 1000 mg in adult human patients with iron deficiency anemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 14
- 主要终点
- To determine the bioequivalence Ferric Carboxymaltose Injection 1000 mg Iron /20mL (50 mg/mL) of RK Pharma Inc. with Ferinject® ɛisencarboxymaltose 50 mg Eisen/ml.
研究概览
简要总结
In this study adult patients with iron deficiency anemia, for whom oral supplementation alone is not adequate or is not appropriate or patients with non-dialysis dependent chronic renal disease will be enrolled. patients will receive either test product or reference product through the IWRS. A total of 27 blood samples (2 x 5 mL each) will be collected. Safety will be evaluated based on general and systemic examination, Vital signs, ECG, Clinical laboratory parameters from baseline and at end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation
- •Patients who have received any of the following medications in recent past: (i) Parenteral iron therapy within the last 6 months prior to randomization (ii) Oral iron therapy within 4 weeks prior to randomization (iii) Erythropoiesis stimulating agents within 3 months prior to randomization (iv) Concomitant medications that may affect the PK results based on investigators discretion
- •Patients with clinically significant or labile hypertension.
- •Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR < 15 mL/min/1.73 m2] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period.
- •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 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 who received whole blood transfusion or red blood cell transfusion or donated blood (1 unit or 350 mL) within 90 days prior to randomization.
- •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 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 theinvestigator’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.
- •Study participants meeting the inclusion and exclusion criteria will be verified by the investigators as per source documents duly authenticated by them, reflecting clinical judgment as and when required.
排除标准
- •Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation
- •Patients who have received any of the following medications in recent past: (i) Parenteral iron therapy within the last 6 months prior to randomization (ii) Oral iron therapy within 4 weeks prior to randomization (iii) Erythropoiesis stimulating agents within 3 months prior to randomization (iv) Concomitant medications that may affect the PK results based on investigators discretion
- •Patients with clinically significant or labile hypertension.
- •Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR < 15 mL/min/1.73 m2] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period.
- •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 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 who received whole blood transfusion or red blood cell transfusion or donated blood (1 unit or 350 mL) within 90 days prior to randomization.
- •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 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.
- •Study participants meeting the inclusion and exclusion criteria will be verified by the investigators as per source documents duly authenticated by them, reflecting clinical judgment as and when required.
结局指标
主要结局
To determine the bioequivalence Ferric Carboxymaltose Injection 1000 mg Iron /20mL (50 mg/mL) of RK Pharma Inc. with Ferinject® ɛisencarboxymaltose 50 mg Eisen/ml.
时间窗: From baseline to End of Study
次要结局
- To assess the safety and tolerability of Ferric Carboxymaltose Injection 1000 mg iron / 20 mL by reported adverse events, laboratory, clinical investigations and vital signs.(From Baseline to end of study)
研究者
研究点 (14)
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