Health Condition 1: N189- Chronic kidney disease, unspecified Health Condition 2: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL) of Mylan Laboratories Limited: The study will consist of a single period. Ferric Carboxymaltose injection 750mg/15mL [50mg/mL] with
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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: o hemoglobin of >= 9.0 g/dL and o Ferritin levels of 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate the single dose, comparative bioavailability of Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL). Timepoint: Within 1 hr prior to dosing, 5.00 mins (after start of slow IV injection), 7.5 mins (after start of slow IV injection). At 20.00 mins, 40.00 mins, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 18.00, 24.00, 30.00, 36.00, 48.00 and 72.00 hours (after start of slow IV injection) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability as assessed by reported adverse events, laboratory and clinical investigationsTimepoint: Vitals at Screening, Day -2 (check in), day0 to 3 Adverse events from screening to end of study Laboratory tests at Screening and end of study Day 3 | — |
Countries
India
Contacts
Public ContactFrancis Micheal
Mylan Laboratories Limited
Outcome results
None listed