CTRI/2023/08/056038已完成未知
A Multicentre, Open Label, Randomized, Single-Dose, Two-Treatment, Parallel Arm Bioequivalence Study of Ferric Carboxymaltose Intravenous Injection (750 mg Iron/15 mL) of Dr. Reddy’s Laboratories Ltd, India, with that of Injectafer®[Ferric Carboxymaltose Injection (750 mg Iron/15 mL)] of American Regent Inc USA under Fasting Condition in Adult Patients with Iron Deficiency Anaemia, for whom Oral Iron Supplementation Alone was Not Adequate or is Not Appropriate. - NA
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 120
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
- •Patients must satisfy all of the following criteria to be included in the study 1. Willing to provide written informed consent indicating that they understand the study requirements and are willing to participate in the study.2. Male and female patients aged between 18 and 65 years (including both).3. Adult patients with iron deficiency anemia, for whom oral supplementation alone was not adequate or is not appropriate in the opinion of the Investigator.4. Patient’s weight within clinically acceptable normal range with minimum of 50 kg body weight at screening visit.5. Haemoglobin value ranging between more than 7 and less than 12 g/dL at screening.6. Ferritin less than or equal to 100 ng/mL or Ferritin less than or equal to 300 ng/mL when TSAT is less than or equal to 30% at screening 7. For Female Patients:• Female patients of childbearing potential must have negative Serum B-hCG (pregnancy test) at screening and Urine Pregnancy test on Day 0 as well as be willing to use a reliable means of contraception (other than hormonal contraceptives) e.g., barrier method (diaphragm, condom, etc.) or abstinence for the duration of the study or • Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the patient) or • Postmenopausal for at least one year based from the last menstrual date.
排除标准
- •Patients with any of the following criteria will be disqualified from entering the study:
- •1. Ongoing pregnancy or lactation for females
- •2. Known hypersensitivity to IMP, excipients, or other iron product
- •3. History of:
- •Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia, sideroblastic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases like CKD, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia
- •Any ongoing acute or chronic infection at screening.
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol.
- •Haemochromatosis or other iron storage disorders.
- •Alcoholism or drug abuse, or severe emotional, behavioural or psychiatric problems within 6 months prior to screening, who may not be able to adequately comply with the requirements of the study.
- •Any active malignancy within 5 years prior to screening.
- •Clinically significant hypertension or labile hypertension.
- •Significant comorbidities like major cardiovascular disease [including myocardial infarction within 6 months prior to study inclusion, congestive heart failure (New York Heart Association III or IV) or poorly controlled hypertension]; uncontrolled endocrinological or metabolic disorders; malignancy, active renal disease, active liver disease, active peptic ulcer, asthma or rheumatoid arthritis.
- •HIV positive or Acquired Immunodeficiency Syndrome (AIDS) related illness, or HIV seropositivity at screening.
- •Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose
- •of investigational intervention.
- •Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.
- •NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
- •Bleeding disorders; acute bleeding or recently documented haemorrhage or recent blood loss leading to hemodynamic instability within 3 months prior to screening
- •5. Receipt of:
- •Medications that may affect PK results within 14 days before screening.
- •Oral iron supplementation within the past 15 days prior to screening.
- •Blood transfusion within 3 months prior to screening, or anticipated
- •need for a blood transfusion during the study.
- •Parenteral iron therapy within the last 3 months prior to screening.
- •Erythropoietin / Erythroid Stimulating Agent treatment within 6 months prior to screening.
- •6. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of IMP.
- •7. Inadequate venous access for PK sampling as judged by investigator.
- •8. Requirement of any planned procedure or hospitalization for pre existing conditions during the study period
研究者
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