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)

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2012

Study Completion Date

July 31, 2012

Conditions
Non-hematological Malignancies
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacosmos A/S

INDUSTRY

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) | Biotech Hunter | Biotech Hunter