CTRI/2022/03/041253已完成未知
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® É?isencarboxymaltose 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 StraÃ?e 29, 81379 München, Deutschland following a single intravenous dose of 1000 mg in adult human patients with iron deficiency anemia. - None
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation
- •2. 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
- •3. Patients with clinically significant or labile hypertension.
- •4. 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.
- •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.
- •6. Patients with hemochromatosis or other iron storage disorders.
- •7. Patients with blood loss leading to hemodynamic instability.
- •8. 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.
- •9. 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.
- •10. Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
- •11. Patients who have HIV or positive hepatitis screen including hepatitis B surface
- •antigen, HCV antibodies and RPR.
- •12. Patients with positive urine alcohol test and drugs of abuse in urine during screening and at check-in.
- •13. Patients who participated in another clinical trial within 60 days prior to
- •randomization.
- •14. 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).
- •15. 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 theinvestigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
- •16. 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
- •1. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation
- •2. 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
- •3. Patients with clinically significant or labile hypertension.
- •4. 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.
- •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.
- •6. Patients with hemochromatosis or other iron storage disorders.
- •7. Patients with blood loss leading to hemodynamic instability.
- •8. 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.
- •9. 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.
- •10. Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
- •11. Patients who have HIV or positive hepatitis screen including hepatitis B surface
- •antigen, HCV antibodies and RPR.
- •12. Patients with positive urine alcohol test and drugs of abuse in urine during screening and at check-in.
- •13. Patients who participated in another clinical trial within 60 days prior to
- •randomization.
- •14. 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).
- •15. 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 investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
- •16. 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
研究者
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