CTRI/2024/11/076426尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Cmax, AUC0-t and AUC0-infinity
研究概览
简要总结
The primary objective of this study is to assess the bioequivalence in adult patients with iron deficiency anaemia, for whom oral iron supplementation alone was not adequate or is not appropriate, under fasting condition
研究设计
- 研究类型
- Ba/be
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide written informed consent indicating that they understand the study requirements and are willing to participate in the study.
- •Male and female patients aged between 18 and 65 years (including both).
- •Adult patients with iron deficiency anaemia, for whom oral supplementation alone was not adequate or is not appropriate in the opinion of the Investigator.
- •Patient’s weight within clinically acceptable normal range with minimum of 50 kg body weight at screening visit.
- •Haemoglobin value ranging between greater than 7 and less than 12 g per dL at screening
- •Ferritin ≤ 100 ng/mL or Ferritin less than or equal to 300 ng per mL when TSAT is ≤30% at screening
- •For Female Patients: Female patients of childbearing potential must have negative Serum β-hCG (pregnancy test) at screening and Urine Pregnancy test on Day 0 as well as be willing to use a reliable means of contrace ption (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
- •Ongoing pregnancy or lactation for females
- •Known hypersensitivity to IMP, excipients, or other iron product
- •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.
- •Known: 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.
- •Receipt of: Medications that may affect PK results within 14 days before screening (Please refer Section 5.1.11).
- •Oral iron supplementation within 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 3-6 months prior to screening.
- •Erythropoietin / Erythroid Stimulating Agent treatment within 6 months prior to screening
- •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.
- •Inadequate venous access for PK sampling as judged by investigator.
结局指标
主要结局
Cmax, AUC0-t and AUC0-infinity
时间窗: 0 hour (pre-dose, within 30 minutes prior to scheduled dosing), 0.083, 0.125 (end of IMP administration), 0.167, 0.250, 0.333, 0.417, 0.500, 0.583, 0.667, 0.833, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 30, 36, 48, 72, 96, 120, | 144 and 168 hours
次要结局
- Tmax, AUC_% Extrap_obs,(t1/2, R2 adjusted and λz)
研究者
Dr Naman Shah
Lambda Therapeutic Research Ltd
研究点 (10)
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