Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric Carboxymaltose Injection 1000 mg iron/20 mL
Manufactured by: Mylan Pharmaceuticals Pvt Ltd, India
: Dose: Single Dose,
Frequency: NA,
Route of Administration: Intravenous,
Duration of Therapy: 30 min �± 5 min.
Control Intervention1: Ferinject
Sponsors
Mylan Pharmaceuticals Pvt Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate or appropriate. 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 per m2 but greater than or equal to 18.5 kg per 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. 8. 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. c. e. History of drug and/or alcohol abuse within one year of randomization. f.. 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. b. 4. Patients with hemochromatosis or other iron storage disorders. 5. 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. 6. Intolerance to venipuncture. 7. Donation or loss of blood or plasma: 50 mL or more within 60 days prior to the administration of study medication. 8. Patients who have received an investigational drug within 60 days prior to the administration of study medication. 9. 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. 10. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation. 11. Subject has clinical signs and symptoms consistent with COVID-19, within the last 28 days prior to screening or on admission. 12. 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, derived from the serum concentration-time curves of Total Iron and Transferrin-bound Iron over 72 hrs.Timepoint: Eight milliliter (2 Ã?â?? 4 mL) blood samples will be collected in plain (red-top) tubes at pre-dose and the multiple time points over 72 hrs during patientsââ?¬â?¢ confinement to site. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of Mylanââ?¬â?¢s Ferric Carboxymaltose Injection 1000 mg iron/20 mLTimepoint: Eight milliliter (2 Ã?â?? 4 mL) blood samples will be collected in plain (red-top) tubes at pre-dose and the multiple time points over 72 hrs during patientsââ?¬â?¢ confinement to site. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed