drugset / Trial / NCT01213680

Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

NCT01213680

Phase 1 Completed 16 enrolled Pharmacosmos A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease

Timeline

Start
2012-02
Primary completion
2012-08
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron isomaltoside 1000 Unknown 500 mg Intravenous
Comparator Iron isomaltoside 1000 Unknown 1000 mg Intravenous