Comparative assessment of the absorption of a generic formulation of ferrous sulfate/sodium ascorbate modified release tablet against the innovator ferrous sulfate/sodium ascorbate modified release tablet conducted under fasting conditions with diet control in healthy male volunteers

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of ferrous sulfate/sodium ascorbate (1 x 325mg /562.4 mg) on one occasion and the innovator formulation of ferrous sulfate/sodium ascorbate (1 x 325mg /562.4 mg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of ferrous sulfate/sodium ascorbate. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 24 hours after dosing. Standard low iron and low fat meals will be consumed at the Clinical Site with no additional food intake allowed. The meal plan has been designed by a Nutritionist with daily iron content approximately 7mg and fat content approximately 16‐21% of total energy per day. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. CONDITION: Iron deficiency. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, ferrous sulfate and vitamin C is an iron supplement indicated for the prevention and treatment of iron deficiency. PRIMARY OUTCOME: To compare the bioavailability of ferrous sulfate/sodium ascorbate (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for ferrous sulfate using one fully validated colorimetric method. Validation will be conducted to comply with EU and FDA guidelines. SECONDARY OUTCOME: Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points. INCLUSION CRITERIA: Healthy males Aged between 18 and 55 Non‐smoker BMI between 18.5 and 30 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent