CTRI/2021/08/036072尚未招募未知
A Multicentre, Open Label, Randomized, Single-Dose, Two-Treatment, Parallel ArmBioequivalence Study of Ferric Carboxymaltose Intravenous Injection (750 mgIron/15 mL) of Dr. Reddyâ??s Laboratories Ltd, India, with that of Injectafer® [FerricCarboxymaltose Injection (750 mg Iron/15 mL)] of American Regent Inc., USA UnderFasting Condition in Adult Patients with Iron Deficiency Anaemia, for whom Oral IronSupplementation Alone was Not Adequate or is Not Appropriate.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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. Willing to provide written informed consent indicating that they understand the study requirements and are willing to participate in the
- •2. Male and female patients aged between 18 and 65 years (including both).
- •3. Patients diagnosed with iron deficiency anaemia, who have intolerance to oral iron or have had unsatisfactory response to oral iron in the opinion of the Investigator.
- •4. Patientâ??s weight within clinically acceptable normal range according to normal values for body mass index 18.50 to 30 kg/m2 (both inclusive) with minimum of 50 kg body weight.
- •5. Haemoglobin value ranging between morethan 7 and lessthan 12 g/dL at screening.
- •6. Ferritin lessthan or equal to 100 ng/mL or less than or equal to 300 ng/mL when TSAT is lessthan or equal to30% at screening
- •7. For Female Patients:
- •- Female patients of childbearing potential must have negative Serum Beta-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 from the last menstrual date
排除标准
- •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
- •- Any chronic disorder or severe disease which, in the
- •opinion of the investigator, might jeopardize
- •patientâ??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
- •- Any active malignancy within 5 years prior to
- •4. Clinically significant hypertension (as per JNC 8
- •recommendations) or clinical diagnosis of labile
- •hypertension, as per investigators judgement.
- •- 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
- •- HIV positive or Acquired Immunodeficiency
- •Syndrome (AIDS) related illness, or HIV
- •seropositivity at screening.
- •- Active or chronic hepatitis B or hepatitis C
- •infection, or Hepatitis B and Hepatitis C
- •seropositivity at screening, if not related to
- •vaccination.
- •- Bleeding disorders; acute bleeding or recently
- •documented haemorrhage or recent blood loss
- •leading to hemodynamic instability within 3 months
- •prior to screening.
- •6. Receipt of:
- •- Medications that may affect PK results within 14
- •days before enrolment.
- •- Oral iron supplementation within the past 1 month
- •prior to screening.
- •- Blood transfusion within 3 months prior to
- •screening, or anticipated need for a blood
- 另有 14 项未显示
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