NCT01280240

Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.

Conditions

• Patients With Chemotherapy Induced Anemia (CIA)

Interventions

Type	Name	Description
DRUG	Monofer(R)	Intravenous bolus injection given over app. 2 minutes only once

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2011-01-20
• Last updated: 2013-06-04

Locations

2 sites across 1 country: United States