CTRI/2020/06/026200进行中（未招募）未知
Multicenter, Single-dose, Randomized, Parallel Arm Two-treatmentBioequivalence Study of Mylanâ??s Iron Dextran (50 mg/mL) versus Allerganâ??sINFeD® (50mg/mL) Following a Single Intravenous Injection in Patients withIron Deficiency Anemia
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 295
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. Age:18 to 65 years
- •2. Sex: Males and/or non-pregnant, non-lactating females.
- •3. Weight: Patients with body weight equal or greater than 50 kg and BMI of 18.5 â?? 30.0 kg/m2.
- •4. Non-Smokers
- •5. Patients diagnosed with iron deficiency anemia, in whom iron deficient state is not amenable to oral iron supplementation and who require parenteral iron dextran for
- •the initial treatment
- •6. Have not received parenteral iron supplementation in the past.
- •7. Patients considered to be suitable for treatment with iron dextran injection based on Investigatorâ??s clinical judgement.
- •9. Adequate venous access in both arms
- •10. Able to understand and sign written Information Consent Form
- •11. Willing to follow the protocol requirements and comply with protocol restrictions
- •12. All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation which include adequate hemopoietic, liver and renal function.
排除标准
- •1. Institutionalized subjects.
- •2. Social Habits include ingestion of alcohol, vitamins or herbal products, nicotine/tobacco containing products and history of drug/alcohol abuse.
- •3. Medications:
- •a. Parenteral iron therapy
- •b. Oral iron therapy
- •c. Erythropoiesis stimulating agents
- •d. Currently on treatment with angiotensin converting enzyme inhibitor drugs or beta blockers
- •e. Concomitant medications that may affect the pharmacokinetic (PK) results
- •4. Diseases:
- •a. Patients considered to be anemic due to other etiology.
- •b. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological,
- •genitourinary, musculoskeletal disease or any other condition or a laboratory value, that in the principal investigatorâ??s judgement, might increase the risk to the
- •c. Patients with known active malignancy
- •d. Patients on hemodialysis or in having acute phase of infectious kidney diseases
- •e. History of tuberculosis
- •f. Patient with history of rheumatoid arthritis
- •g. Hemochromatosis or other iron storage disorders
- •h. History of Blood loss.
- •i. History of major surgery or invasive intervention, organ transplant . Acute illness at the time of either the pre-study medical evaluation or dosing
- •k. history of significant allergies and/or asthma
- •5. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study
- •6. Intolerance to venipuncture
- •7. Received whole blood transfusion or red blood cell transfusion or donated blood (1 unit or 350 mL) within 90 days prior to randomization
- •8. Donation or loss of blood or plasma
- •9. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication
- •10. Any food allergy, intolerance, restriction or special diet
- •11. Allergy or hypersensitivity to iron dextran, other related products, or any inactive ingredients
研究者
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