PK Study of Ferric Carboxymaltose injection in Iron deficiency anemia patients.
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2023/07/054917
- Lead Sponsor
- Orbicular Pharmaceutical Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the PK parameters: maximum serum concentration (Cmax) & area under the serum concentration-time curve (AUC) for TI.Timepoint: Total 23 blood including pre-dose sample till 72 hrs. post dose will be collected.
- Secondary Outcome Measures
Name Time Method Time of the maximum measured serum concentration (Tmax), area under the concentration-time curve extrapolated to infinity (AUC0-inf), apparent terminal rate constant (Kel), apparent terminal half-life (t1/2), systemic clearance after intravenous dosing (CL), & volume of distribution following intravenous dosing (Vd) for TI and TBI.Timepoint: Total 23 blood including pre-dose sample till 72 hrs. post dose will be collected.