Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Manufactured by: Mylan laboratories Ltd, India
: Dose: 750 mg iron/15 mL,
Duration: 30 Minutes (via Infusion Pump),
Mode of Administration: Intravenous
Control Intervention1: Injectafer�® (ferric
Sponsors
Dr Sanjeev Hegde
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/appropriate or with non-dialysis dependent chronic renal disease (as defined by either (i) GFR 2. Age: Between the ages of 18 and 65 years. 3. Sex: Males and/or non-pregnant, non-lactating females.. 4. Weight: Each patient is required to weigh at least 50 kg (110 lbs) and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2. 5. Smoking Status: Non-smokers preferred, however, up to moderate smokers are permitted. 6. Able to understand and sign the written Informed Consent Form. 7. Willing to follow the protocol requirements and comply with protocol restrictions. All patients should be judged by the Principal Investigator or Medical Sub-Investigator as normal and relatively healthy (excluding iron-deficiency anemia) during a pre-study medical evaluation
Exclusion criteria
Exclusion criteria: 1. Institutionalized patients. 2. Social Habits: a. Ingestion of any alcoholic beverage, caffeine- or xanthine-containing food or beverage, any vitamins or herbal products prior to the initial administration of study medication. b History of drug and/or alcohol abuse within one year of randomization. 3. Medications: a. Parenteral iron therapy within the last 6 months prior to the initial dose of study medication. b. Oral iron therapy within 14 days prior to randomization. c. Erythropoiesis stimulating agents within 3 months prior to the initial dose of study medication. d. Diseases: History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed clinically non-significant by the Principal Investigator or Medical Sub-Investigator. 4. Patients diagnosed with iron deficiency anaemia for whom oral supplementation alone is not adequate/appropriate. 5. Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR 6. 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. 7. Intolerance to venipuncture. 8. Donation or loss of blood or plasma: 50 mL or more within 60 days prior to the administration of study medication. 9. Patients who have received an investigational drug within 60 days prior to the administration of study medication. 10. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the patientââ?¬•s participation in this study. 11. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation. 12. Subject has clinical signs and symptoms consistent with COVID-19, within the last 28 days prior to screening or on admission. Subject who had severe course of COVID-19 (extracorporeal membrane oxygenation (ECMO), mechanically ventilated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistical comparison of various pharmacokinetic parameters, CPEAK , AUCL and & AUCINF derived from the serum concentration-time curves of Total Iron. Transferrin bound iron data will be supportive. Timepoint: Day ââ?¬â?? 01: Pre-dose (0.00)-No earlier than 90 minutes prior to dosing Day ââ?¬â?? 01: 5 and 15 min_During infusion Ã?± 2 min Day ââ?¬â?? 01: 30 min (immediately prior to the completion of the infusion)_ During infusion Ã?± 2 min Day ââ?¬â?? 01: 35 min (five minutes after the completion of the infusion) and 45 min_ Ã?±2 min Day ââ?¬â?? 01: 1, 2, 4, 6, 8 hr_ Ã?±2 min Day ââ?¬â?? 01: 10, 12, 16, 20 hr_ Ã?±30 min Day ââ?¬â?? 02: 24, 28, 32, 36 hr_Ã?±30 min Day ââ?¬â?? 03: 48, 60 hr_Ã?±30 min Day ââ?¬â?? 04: 72 hr_Ã?±30 min | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of Mylanââ?¬â?¢s Ferric Carboxymaltose Injection 750 mg iron/15 mL.Timepoint: Day ââ?¬â?? 01: Pre-dose (0.00)-No earlier than 90 minutes prior to dosing Day ââ?¬â?? 01: 5 and 15 min_During infusion Ã?± 2 min Day ââ?¬â?? 01: 30 min (immediately prior to the completion of the infusion)_ During infusion Ã?± 2 min Day ââ?¬â?? 01: 35 min (five minutes after the completion of the infusion) and 45 min_ Ã?±2 min Day ââ?¬â?? 01: 1, 2, 4, 6, 8 hr_ Ã?±2 min Day ââ?¬â?? 01: 10, 12, 16, 20 hr_ Ã?±30 min Day ââ?¬â?? 02: 24, 28, 32, 36 hr_Ã?±30 min Day ââ?¬â?? 03: 48, 60 hr_Ã?±30 min Day ââ?¬â?? 04: 72 hr_Ã?±30 min | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed