drugset / Trial / NCT01213979

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

NCT01213979

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 non-hematological malignancies with Chemotherapy induced anaemia.

Timeline

Start
2012-02
Primary completion
2012-05
Completion
2012-07

Drugs

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

Indications

No indication recorded.