CTRI/2023/07/054917招募中Unknown
An open-label, randomized, multi-center, single-dose, parallel, two-treatment, pharmacokinetic bioequivalence (BE) study of Ferric Carboxymaltose injection 750 mg/15 mL manufactured for Orbicular Pharmaceutical Technologies Pvt Ltd., India with Injectafer® (Ferric Carboxymltose injection) 750 mg/15 mL of American Regent Inc. in adult patients with iron deficiency anemia under fasting condition. - NI
Orbicular Pharmaceutical Technologies Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
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.Subjects who are able and willing to give written informed consent
- •2.Subjects who are willing to comply with all study procedures and are available for the duration of the study
- •3.Male and female subjects aged 18 to 65 years (both inclusive)
- •4.Subjects with body weight of 50 kg or above
- •5.Subjects with body mass index (BMI) value within 18.50 kg/m2 to 25.00 kg/m2, inclusively
- •6.Subjects with iron deficiency anemia, having intolerance or had unsatisfactory response to oral iron
- •7.Subjects who have prescriptions for treatment with ferric carboxymaltose injections
- •8.Acceptable hematological status
- •9.Acceptable liver function:
- •10.Subjects who are negative for hepatitis B antigen test, hepatitis C antibody test, and human immunodeficiency virus (HIV) tests at screening
- •11.Adequate venous access in both arms for the collection of a number of blood samples during the study
- •12.No history of addiction to any recreational drug or drug dependence or alcohol addiction
- •13.Female subjects of child bearing potential with a negative serum pregnancy test at screening and negative urine pregnancy test on Day -2
- •14.Women of child bearing potential and practicing acceptable methods of contraception during the study.
排除标准
- •1. Subjects with chronic kidney disease who are on dialysis of any kind
- •2. History of any important clinically significant disease or disorder that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influences the results or the subjects ability to participate in the study
- •3. Any abnormal laboratory value that in the Investigators judgement would interfere with study participation
- •4. Any clinically important illness, medical or surgical procedure, or trauma within 4 weeks of hospitalization or any intervention planned during the course of the study
- •5. Subjects with blood loss leading to hemodynamic instability and/or subjects who have donated blood within 90 days prior to hospitalization
- •6. Subjects with parenteral iron therapy within 6 months prior to hospitalization
- •7. Subjects who have received a blood transfusion within 90 days prior to hospitalization
- •8. Subjects who have used oral iron therapy within 14 days of screening and an erythropoiesis-stimulating agent (ESA) for treatment of anemia within 30 days of screening
- •9. Subjects with hemochromatosis or other iron storage disorders
- •10. Subjects with any active malignancy within 5 years prior to screening
- •11. Smokers who smoke greater than or equal to 10 cigarettes or equivalent per day
- •12. Pregnant or lactating women
- •13. Subjects with known hypersensitivity to ferric carboxymaltose, excipients, similar products or any other iron preparation
- •14. Subjects with possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, hyperparathyroidism, vitamin D deficiency, malnutrition and concurrent or prior use of medications that affect proximal renal tubular function
- •15. Subjects with clinically significant or labile hypertension
- •16. Subjects with Glomerular Filtration Rate (GFR) less than 60 ml per min
- •17. Participation in any clinical study within 90 days before IP administration
- •18. Significant comorbidities or concomitant medications that may affect PK results
- •19. Subjects who are unable to fast
- •20. Subjects who have intolerance to direct venipuncture
- •21. Subjects who has clinical signs and symptoms consistent with COVID-19
研究者
相似试验
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