Iron-Deficiency Clinical Trial
Official title:
A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects Aged 10-17 Years of Age With Iron Deficiency
The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.
Phase I, open label, randomized, repeat dose, multicentre, pharmacokinetic study to assess the Safety and Tolerability of Ferric Maltol in 3 different dosages. 36 eligible patients will be randomized in a 1:1:1 ratio to one of the following 3 dosages for 9 days BID and a single dose on Day 10: - 30mg ferric maltol capsules - 16.6 mg ferric maltol capsules - 7.8 mg ferric maltol capsules Subject participation in the study will consist of 3 stages: Screening: up to 14 days Treatment period: 10 days treatment period with 2 visits on Day 1 and Day 10 for PK blood sampling. Patients will be randomly allocated to one of the three Ferric Maltol dose groups according to centralized treatment allocation scheme. Post-treatment Safety Follow-up:3-10 days following completion of the treatment period or premature discontinuation of study medication ;
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