Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers

Inclusion Criteria: * Male healthy volunteers within the age range of 18 to 45 years (both inclusive) * Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure * Subjects of good health based on previous medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests assessed at the time of screening * Ferritin levels ≥ 30 µg/l * Transferrin ≥ 200 mg/dl * Hemoglobin levels ≥ 13.5 g/dl Exclusion Criteria: * Subjects with a BMI of \< 19 kg/m2 and \> 30 kg/m2 * History of iron deficiency within six months prior screening * History of anemia within 1 year prior screening * Presence of iron overload or disturbances in utilization of iron * History or evidence of allergy or hypersensitivity to the active substance Iron Sucrose of both test and reference product, the finished test and reference product or any of its excipients (water for injection, sodium hydroxide) * Hypersensitivity to other parenteral iron products * Use of iron supplements or iron containing herbal or nutritional supplements within last three months prior to start of the study * History of difficulty with donating blood or difficulty in accessibility of veins in left and right arm * Donation of blood (one unit or 350 mL) within last three months prior first dose administration of the study drug * Evidence of an active or suspected cancer, or a history of malignancy within the last 2 years, with the …