Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Iron-Dextran Injection: 50mg/ml, 2ml intravenous,
Single dose, One day
Control Intervention1: INFeD®
(IRON DEXTRAN INJECTION USP): 50mg/ml, 2ml , intravenous
Single dose, One day
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age:18 to 65 years 2. Sex: Males and/or non-pregnant, non-lactating females. 3. Weight: Patients with body weight equal or greater than 50 kg and BMI of 18.5 â?? 30.0 kg/m2. 4. Non-Smokers 5. Patients diagnosed with iron deficiency anemia, in whom iron deficient state is not amenable to oral iron supplementation and who require parenteral iron dextran for the initial treatment 6. Have not received parenteral iron supplementation in the past. 7. Patients considered to be suitable for treatment with iron dextran injection based on Investigatorâ??s clinical judgement. 9. Adequate venous access in both arms 10. Able to understand and sign written Information Consent Form 11. Willing to follow the protocol requirements and comply with protocol restrictions 12. All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy during a pre-study medical evaluation which include adequate hemopoietic, liver and renal function.
Exclusion criteria
Exclusion criteria: 1. Institutionalized subjects. 2. Social Habits include ingestion of alcohol, vitamins or herbal products, nicotine/tobacco containing products and history of drug/alcohol abuse. 3. Medications: a. Parenteral iron therapy b. Oral iron therapy c. Erythropoiesis stimulating agents d. Currently on treatment with angiotensin converting enzyme inhibitor drugs or beta blockers e. Concomitant medications that may affect the pharmacokinetic (PK) results 4. Diseases: a. Patients considered to be anemic due to other etiology. b. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or any other condition or a laboratory value, that in the principal investigatorâ??s judgement, might increase the risk to the patient c. Patients with known active malignancy d. Patients on hemodialysis or in having acute phase of infectious kidney diseases e. History of tuberculosis f. Patient with history of rheumatoid arthritis g. Hemochromatosis or other iron storage disorders h. History of Blood loss. i. History of major surgery or invasive intervention, organ transplant . Acute illness at the time of either the pre-study medical evaluation or dosing k. history of significant allergies and/or asthma 5. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study 6. Intolerance to venipuncture 7. Received whole blood transfusion or red blood cell transfusion or donated blood (1 unit or 350 mL) within 90 days prior to randomization 8. Donation or loss of blood or plasma 9. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication 10. Any food allergy, intolerance, restriction or special diet 11. Allergy or hypersensitivity to iron dextran, other related products, or any inactive ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence of Mylanâ??s Iron Dextran (50mg/mL) versus Allerganâ??s INFeD® (50 mg/mL), in male and female patients with iron deficiency anemia under fasting conditions and to assess the safety and tolerability of Iron Dextran Injection 50 mg/mLTimepoint: 26 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed