Anemia, Iron Deficiency Clinical Trial
Official title:
A Randomized, Open-Label, Single Dose, Four-Way Crossover, Phase I Study to Compare the Pharmacokinetics of Ferric Maltol Capsules and Oral Suspension Under Fasted and Fed Conditions in Adult Healthy Volunteers
The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.
Open-label, Phase 1, four way crossover study to compare the PK of the new ferric maltol suspension, in healthy volunteers, with the existing ferric maltol capsules under fed and fasted conditions. 32 subjects will be randomised to 1:1:1:1 ratio to receive one of the treatment sequences. Based on the randomised sequence, subjects will receive a single dose of 30mg ferric maltol capsule in a fed/ fasted condition and 30 mg (5ml) ferric maltol suspension in a fed/ fasted condition. Subject participation in the study will consist of 3 periods: 1. Screening: up to 14 days 2. Randomised treatment: 8 days 3. Post-treatment follow up: 3-7 days following drug discontinuation ;
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