Comparative assessment of the absorption of an Iron Polymaltose tablet against an innovator product conducted in iron deficient participants under fed conditions with diet control (low iron and low fat).

Single dose, crossover study design whereby each participant receives the test formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide 370mg tablet on one occasion and the innovator formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide 370mg tablet on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of iron(3+);(2R,3S,4R,5R)-2,3,4,5-tetrahydroxy-6-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexanal;trihydroxide. Each dose is separated by a one week washout period. 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 a low fat / low iron content breakfast 30 minutes prior to dosing 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 12 hours prior to dosing to ensure compliance and will be monitored for 26 hours after dosing. For a period of 7 days prior to dose administration in period 1, until 36 hours after dose administration in period 2, participant’s food intake will be controlled with a diet low in iron and fat (16 days in total). All meals and snacks will be reviewed for nutritional balance (using appropriate levels of protein, fat and carbohydrate) and all food will be supplied to participants to consume either at home during the pre-study run in and washout period, and at the Clinical Site during the confinement periods. The meal plan has been designed by a Dietician and the low fat / low iron breakfast on study days 8 and 15 consist of a total calorie content of 462.46 kcal and Iron content of 0.84 mg. The daily standard meals composition will be determined by the dietician prior to the study commencing. Alcohol breath testing and urine drugs of abuse testing and urine pregnancy testing (participants of childbearing potential only) will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Pre and post study laboratory tests and procedures 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.