CTRI/2023/10/058814OtherUnknown
A randomized, open label, multi-center, single dose, parallel, two-treatment, single-period, pharmacokinetic bioequivalence (BE) study of Chemi Ferric Carboxymaltose Injection 750 mg/15 mL of Chemi S.p.A. part of Italfarmaco group versus Injectafer® (Ferric Carboxymaltose Injection) 750 mg/15 mL of American Regent, Inc., in adult patients with iron deficiency anemia under fasting condition. - NI
ITALFARMACO S.p.A.0 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
- Other
- 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
- •The patients will be considered eligible for the study based on the following criteria:
- •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 or female subjects aged 18 to 75 years (both inclusive) having Body Mass Index (BMI) value within 18.50 kg per m2 to 30.00 kg per m2, inclusively
- •4. Subjects with body weight of 50 kg or above
- •5. Subjects with iron deficiency anemia, having intolerance or had unsatisfactory response to oral iron
- •6. Subjects who have prescriptions for treatment with ferric carboxymaltose injections
- •7. Acceptable hematology status:
- •a. Hemoglobin 8-12 g per dL
- •b. Ferritin less than or equal to 100 ng per mL or less than or equal to 300 ng per mL when TSAT is less than or equal to 30 percent
- •c. Serum iron level less than 10.7 micro mol per L or less than 60 micro g per dL
- •8. Acceptable Liver Function
- •a. Alanine aminotransferase (ALT) less than or equal to 2 X upper limit of normal (ULN)
- •b. Aspartate aminotransferase (AST) less than or equal to 2 X ULN
- •c. Bilirubin less than or equal to 1.5 X ULN
- •d. Alkaline phosphatase less than or equal to 2 X ULN
- •9. Subjects who are negative for hepatitis B antigen test (HBsAg), hepatitis C antibody test, and human immunodeficiency virus tests at screening
- •10. Adequate venous access in both arms for the collection of a number of blood samples during the study
- •11. No history of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months prior to hospitalization
- •12. Female subjects of childbearing potential with a negative serum pregnancy test at screening and negative urine pregnancy test on Day -2
- •13. Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using an effective method of contraception during dosing of the investigational product) practicing acceptable methods of contraception during the study
- •Acceptable methods of contraception are
- •a. Oral, parenteral (injection), patch or implant hormonal contraception
- •b. Intrauterine device or intrauterine system
- •c. Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
- •d. Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that subject)
- •e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
- •f. Total abstinence; partial abstinence is not acceptable
排除标准
- •The patients will be excluded from the study based on the following criteria:
- •1. Subjects with known hypersensitivity to ferric carboxymaltose, excipients, similar products or any other iron preparation
- •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 Investigator’s 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 before IP administration
- •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 prior to hospitalization and an erythropoiesis-stimulating agent for treatment of anemia within 30 days prior to hospitalization
- •9. Subjects with hemochromatosis or other iron storage disorders
- •10. Subjects with hematology status including absolute neutrophil count less than or equal to 1500 cells per micro L and Platelet count less than or equal to 75,000 cells per micro L
- •11. Subjects with any active malignancy within 5 years prior to screening
- •12. Smokers who smoke greater than or equal to 10 cigarettes or equivalent per day
- •13. Pregnant or lactating women
- •14. Surgical or other non-healing wounds
- •15. Subjects with possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, inflammatory bowel disease, hyperparathyroidism, vitamin D deficiency, malnutrition and concurrent or prior use of medications that affect proximal renal tubular function and symptomatic hypophosphatemia assessed by investigator
- •16. Subjects with clinically significant (systolic more than 160 mmHg and or diastolic more than 100 mmHg) or labile hypertension
- •17. Any ongoing acute or chronic infection or clinical symptoms suggesting systemic infection at screening
- •18. Subjects with Glomerular Filtration Rate less than 60 ml per min as estimated by using the Cockcroft-Gault equation
- •19. Participation in any clinical study within 90 days before IP administration
- •20. Significant comorbidities or concomitant medications that may affect PK results
- •21. Subjects who are unable to fast for at least 10 hours before IP administration
- •22. Subjects who have intolerance to direct venipuncture
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