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

Open-label Pharmakokinetic Study of Iron Isomaltoside 1000 (Monofer)Administered by 500 mg IV Injection or 1000 mg Intravenous Infusion to Patients With Inflammatory Bowel Disease (PK-IBD-02)

• 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 inflammatory bowel disease

Conditions

• Inflammatory Bowel Disease

Interventions

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

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2010-10-04
• Last updated: 2013-11-14