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)

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)(PK-CIA-04)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-hematological Malignancies

Interventions

Type	Name	Description
DRUG	500 mg iron isomaltoside 1000	500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes
DRUG	1000 mg iron isomaltoside 1000	1000 mg iron isomaltoside 1000 given as a infusion over 15 minutes

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2010-10-04
• Last updated: 2013-06-27