drugset / Trial / NCT03181451
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
RandomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2017-03-14
- Primary completion
- 2018-03-28
- Completion
- 2018-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric maltol | Small molecule | 7.8 mg | — |
| Comparator | Ferric maltol | Small molecule | 16.6 mg | — |
| Comparator | Ferric maltol | Small molecule | 30 mg | — |