It is a multicenter, randomized, single dose, parallel, two treatment, comparative, open label, bioequivalence study of Ferric Carboxymaltose Injection, 50 mg/ml (750mg/15ml) of Emcure Pharmaceutical Limited, with INJECTAFER® (ferric carboxymaltose injection), 750 mg iron/15ml of American Reagent, Inc., in adult patients with iron deficiency anemia, for whom oral supplementation alone was not adequate or is not appropriate. 22 adult male and female patients will be randomized to get 18 evaluable subjects. Patients will be housed at least 36.00 hours prior to drug dosing and until at least 168.00 hours after dosing. Primary objective: To assess the bioequivalence of Ferric Carboxymaltose Injection 50 mg/ml (750mg/15ml) of Emcure Pharmaceutical Limited with INJECTAFER® (ferric carboxymaltose injection) of American Reagent, Inc., 750 mg iron/15ml, to adult patients with iron deficiency anemia.
Secondary objective: To assess the safety and tolerability of Emcure’s Ferric Carboxymaltose Injection 50 mg/ml (750mg/15ml) with INJECTAFER® (ferric carboxymaltose injection), 750 mg iron/15ml based upon reported adverse events, clinical laboratory results, clinical investigations, and vital signs. Blood samples will be collected prior to dosing and for 168.00 hours after drug dosing. Inclusion Criteria:1. 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 performed within 28 days of the initial dose of study medication which will include: a. A normal or clinically non- significant physical examination, including vital signs (blood pressure, pulse rate, respiratory rate and temperature). Acceptable range for vital signs is as follows: 1. Systolic blood pressure between 100-140 mmHg and diastolic blood pressure 60-90 mmHg. 2. Pulse rate 60-100 bpm, respiratory rate 12-20 breaths per minute. 3. Axillary temperature 96.0–99.0°F. During screening, vital signs may be repeated once (unless otherwise specified). If the repeat measurement remains outside of the acceptable range, the Principal Investigator or Medical Sub-Investigator will determine the appropriate course of action. If the subject is permitted to enter the study, then written justification is required. b. Within normal limits or clinically non-significant laboratory evaluation results for the following tests (unless otherwise noted below or in the Exclusion Criteria): Serum Chemistries | Sodium | Potassium | Chloride | BUN | | Prothrombin time | Albumin | Total Protein | AST | | Alkaline Phosphatase | Calcium | Creatinine | ALT | | Total Bilirubin | Total Cholesterol* | Phosphate | | | Uric Acid | Glucose* | Triglycerides* | | *Fasting or non-fasting may be performed based on clinical judgment i. AST and ALT ≤ 3 times ULN, ii. Alkaline phosphatase ≤ 2.5 times ULN, iii. Bilirubin ≤ 1.5 times ULN · Haematology Platelet Count White Blood Cell Count WBC /Differential Haemoglobin Haematocrit Red Blood Cell Count i. Haemoglobin of < 12g/dL at screening ii. ANC ≥ 1500/mm3 iii. Platelet count ≥ 100,000/mm3 Urinalysis : 1 . Appearance 2. Specific Gravity 3. Protein 4. pH 5. Microscopic Examination (performed based on clinical judgment) 2. Additional tests may be performed, if necessary, based on standard lab panels utilized by the clinical site. 3. Normal or clinically nonsignificant 12-lead ECG. 4. Negative Hepatitis B antigen test. 5. Negative Hepatitis C antibody test. 6. Negative HIV test. 7. Negative chest X-ray for tuberculosis. A negative chest X-ray acquired within 6 months of study start and having adequate documentation available is acceptable at the discretion of the Principal Investigator or responsible physician. 8. Tests for other sexually transmitted diseases (STD) may be performed at the discretion of the Principal Investigator or responsible physician, 9. Negative urine drug screen including at a minimum amphetamines, barbiturates, benzodiazepines, cannabinoid, cocaine, and opiates. Note: If warranted, other tests and/or examinations may be performed at the discretion of the Principal Investigator or responsible physician to determine patient eligibility. Any additional tests used to confirm patient’s eligibility are to be included in the patient’s CRF. The schedule of the patient’s visit at study site will be as follows:
-Screening visit(-28 days) -Day (-2) (Check in -36.00 hours) -Day (-1) (-24.00 hours) -Days 1 to Day 4 (In house treatment period) -Day 4 (Check-out 168.00 hours) -End of Study/ Safety follow-up visit
Exclusion Criteria: 1. Diseases:a) 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) Patients with known active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia). Blood loss leading to hemodynamic instability. c) History of tuberculosis. d) Glomerular Filtration Rate (GFR) less than 60 ml/min as estimated by using the Cockcroft-Gault equation. Males: CLCr = [140-age(years) x weight(kg)] / 72x serum creatinine(mg/dl) Females: CLCr= [140-age(years) x weight( kg) x 0.85 / 72 x serum creatinine(mg/dl) 2.Patients with clinically significant or labile hypertension. f) 3. Patients with significant comorbidities such as congestive heart failure, asthma, decompensated liver cirrhosis, eczema or atopic allergy, acute/chronic infection of any type, systemic lupus erythematous, rheumatoid or inflammatory arthritis, inflammatory bowel disease, rheumatic disease or any other condition, that in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data. g) 4.Acute illness at the time of either the pre-study medical evaluation or at the time of dosing. 1. Donation or loss of blood or plasma: 50 mL or more within 90 days prior to the administration of study medication. 2. Patients who have received an investigational drug within 90 days prior to the administration of study medication. 3. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the patient’s participation in this study.
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