CTRI/2022/10/046637已完成未知
A multicenter, open label, balanced, randomized, single-dose, two-treatment, single period, parallel bioequivalence study of Ferric carboxymaltose solution for injection/infusion (50 mg iron/mL) of Dr. Reddys Laboratories Ltd, India, with that of Ferinject® [Ferric carboxymaltose solution for injection/infusion (50 mg iron/mL)] of Vifor Pharma UK Limited, TW18 3BA, UK in patients with iron deficiency anemia, for whom oral iron preparations are ineffective or cannot be used, under fasting condition.
Dr. Reddy’s Laboratories Ltd.0 个研究点目标入组 155 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 155
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. Male and female patients with age 18-65 (inclusive of both) years.
- •2. Patients weight within clinically acceptable normal range according to normal values for Body Mass Index (18.50 to 24.90 kg/m2 (both inclusive) with minimum of 50 kg body weight.
- •3. Patients that have Iron Deficiency Anemia
- •(IDA) at the time of screening based on
- •following laboratory parameters:
- •a.Hemoglobin value >7 and <12 g/dL at
- •b. Ferritin = 100 ng/mL or = 300 ng/mL when
- •TSAT is = 30% at screening.
- •4. Patients that meet either of the following criteria:
- •4(a)Unsatisfactory response to oral iron in the opinion of the
- •Investigator based on the history of having received oral iron
- •4(b)Intolerance to oral iron preparations or where oral iron
- •preparations cannot be used as per the Investigator.
- •5. Patients requiring total iron of at least 1000 mg based on individual assessment of iron deficiency by the Investigator.
- •6. Patients willing to adhere to the protocol requirements and to provide written informed consent.
- •7. Patients able to understand and comply with the study procedures, in the opinion of the investigator.
- •8. For Female patients:
- •8(a)Female of child bearing potential having negative Serum ß-hCG
- •(pregnancy test) at screening and Urine Pregnancy test at admission
- •and practicing an acceptable method of birth control for the
- •duration of the study as judged by the investigator(s), such as
- •condoms, foams, jellies, diaphragm, intrauterine device (IUD), or
- •abstinence, OR
- •8(b)Postmenopausal for at least 01 year from the last menstrual date, OR
- •8(c)Surgically sterile (bilateral tubal ligation, bilateral
- •oophorectomy, or hysterectomy has been performed on the subject).
排除标准
- •1.Ongoing pregnancy or lactation.
- •2.Known hypersensitivity to Investigational medicinal Product, excipients, or other parenteral iron products.
- •3.History of:
- •3(a)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.
- •3(b)Known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
- •3(c)Haemochromatosis or other iron storage / disturbances in the utilisation of iron disorders or evidence of iron overload.
- •3(d)Clinically significant (systolic >160 and/or diastolic >100) or labile hypertension
- •3(e)Any ongoing acute or chronic infection or ongoing bacteremia at screening.
- •3(f)Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol.
- •3(g)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.
- •3(h)Any active malignancy within 5 years prior to screening.
- •4(a)Significant comorbidities like major cardiovascular disease uncontrolled endocrinological or metabolic disorders; malignancy, active renal disease, active liver disease, active peptic ulcer, asthma or rheumatoid arthritis.
- •4(b)Liver dysfunctions including particular Porphyria Cutanea Tarda (PCT) or elevated serum transaminases to more than three times the upper limit of normal (ULN)
- •4(c)HIV positive or Acquired Immune deficiency Syndrome (AIDS) related illness, or HIV seropositivity at screening.
- •4(d)Active or chronic Hepatitis B or Hepatitis C infection, or Hepatitis B and / or Hepatitis C seropositivity at screening, if not related to vaccination.
- •4(e)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:
- •5(a)Medications that may affect PK results within 14 days before enrolment.
- •5(b)Oral iron supplementation within the past 14 days prior to screening.
- •5(c)Blood transfusion within 3 months prior to screening, or anticipated need for a blood transfusion during the study.
- •5(d)Parenteral iron therapy within the last 3 months prior to screening.
- •5(e)Erythropoietin/Erythroid Stimulating Agent treatment within 6 months prior to screening.
- •6.Patients who are on sodium controlled diet.
- •7.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IMP.
- •8.Inadequate venous access for PK sampling as judged by investigator.
- •9.Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period.
- •10.Patients found positive on urine scan for drugs of abuse and/or breath test for alcohol consumption at screening and at the time of check-in and drinking more than five cups of xanthine-containing beverages per day.
- •11.The receipt of an investigational medicinal product or participation in other drug resea
研究者
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