CTRI/2018/09/015767已完成未知
A multicenter, randomized, single-dose, parallel, two-treatment, bioequivalence study of Mylanâ??s Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL) with American Regent INCâ??s INJECTAFER® (Ferric Carboxymaltose Injection 750mg/15mL [50mg/mL]) following a single intravenous dose of 750mg in adult male and female patients with iron deficiency anemia - IDA
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 238
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.Men or non-pregnant, non-lactating females aged 18-65 years (both inclusive)
- •2.Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/not appropriate or with non-dialysis dependent chronic renal disease.
- •3.Patients considered to be suitable for treatment with Ferric Carboxymaltose Inj. based on Investigator judgement.
- •4.Patients with body weight >= 50 kg at screening and check in, with BMI of 18.5 â?? 30.0 kg/m2 at the time of screening.
- •5.Patients with Iron status at screening defined as:
- •ohemoglobin of >= 9.0 g/dL and < 12g/dL at screening
- •oFerritin levels of <= 100 ng/mL (or <= 300ng/mL when TSAT is <=30%)
- •6.Patients with adequate hematopoeitic and liver function at screening
- •7.Female patients should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral oophorectomy; or practicing an acceptable form of birth control starting 60 days prior to dosing in case of women with a childbearing potential and prepared to continue for at least 30 days following the last treatment.
- •8.Patient or LAR willing to provide written informed consent to participate. Patient agrees to comply with the study procedures and requirements of the study.
排除标准
- •1.Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation.
- •2.Patients who have received any of the following medications in recent past:
- •a.Parenteral iron therapy
- •b.Oral iron therapy
- •c.Erythropoiesis stimulating agents
- •d.Concomitant medications that may affect the PK results based on investigators discretion.
- •3.Patients with clinically significant or labile hypertension.
- •4.Patients with Stage 5 Chronic Kidney Disease (CKD)
- •5.Patients considered to be anemic due to other aetiology..
- •6.Patients with hemochromatosis or other iron storage disorders.
- •7.Patients with blood loss leading to hemodynamic instability.
- •8.Patients who had major surgery or invasive intervention within 4 weeks prior to screening, organ transplant within 6 months prior to screening, or have a surgery or intervention planned during the course of the study.
- •9.Patients who received whole blood transfusion or red blood cell transfusion or donated blood within 90 days prior to randomization.
- •10.Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
- •11.Patients who have HIV or positive hepatitis screen including hepatitis B surface antigen, HCV antibodies.
- •12.Patients with positive alcohol breath test on the day of check-in.
- •13.Patients who participated in another clinical trial within 60 days prior to randomization.
- •14.Patients with known active malignancy
- •15.Patients with significant comorbidities that in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
研究者
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