CTRI/2021/07/034733进行中（未招募）未知
A Multicenter, Randomized, Single-Dose, Parallel, Two Treatment, Bioequivalence Study of Mylanâ��s Ferric Carboxymaltose Injection 750 mg/15 mL with American Regentâ��s Injectafer�® Following a Single Intravenous Dose of 750 mg in One Hundred and Fifty Adult Male and Female Patients with Iron Deficiency Anemia. - NA
Dr Sanjeev Hegde0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/appropriate or with non-dialysis dependent chronic renal disease (as defined by either (i) GFR <60 mL/min/1.73m2 on screening (as calculated by MDRD, or (ii) GFR <90 mL/min/1.73m2 during screening & at least 1 marker of kidney damage based on medical history within 3 months of screening).
- •2. Age: Between the ages of 18 and 65 years.
- •3. Sex: Males and/or non-pregnant, non-lactating females..
- •4. Weight: Each patient is required to weigh at least 50 kg (110 lbs) and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2.
- •5. Smoking Status: Non-smokers preferred, however, up to moderate smokers are permitted.
- •6. Able to understand and sign the written Informed Consent Form.
- •7. Willing to follow the protocol requirements and comply with protocol restrictions.
- •All patients should be judged by the Principal Investigator or Medical Sub-Investigator as normal and relatively healthy (excluding iron-deficiency anemia) during a pre-study medical evaluation
排除标准
- •1. Institutionalized patients.
- •2. Social Habits:
- •a. Ingestion of any alcoholic beverage, caffeine- or xanthine-containing food or beverage, any vitamins or herbal products prior to the initial administration of study medication.
- •b History of drug and/or alcohol abuse within one year of randomization.
- •3. Medications:
- •a. Parenteral iron therapy within the last 6 months prior to the initial dose of study medication.
- •b. Oral iron therapy within 14 days prior to randomization.
- •c. Erythropoiesis stimulating agents within 3 months prior to the initial dose of study medication.
- •d. Diseases:
- •History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed clinically non-significant by the Principal Investigator or Medical Sub-Investigator.
- •4. Patients diagnosed with iron deficiency anaemia for whom oral supplementation alone is not adequate/appropriate.
- •5. Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR < 15 mL/min/1.73 m2 estimated using the MDRD equation] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period..
- •6. 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.
- •7. Intolerance to venipuncture.
- •8. Donation or loss of blood or plasma: 50 mL or more within 60 days prior to the administration of study medication.
- •9. Patients who have received an investigational drug within 60 days prior to the administration of study medication.
- •10. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the patientââ?¬•s participation in this study.
- •11. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation.
- •12. Subject has clinical signs and symptoms consistent with COVID-19, within the last 28 days prior to screening or on admission.
- •Subject who had severe course of COVID-19 (extracorporeal membrane oxygenation (ECMO), mechanically ventilated).
研究者
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