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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-06-27

No results posted yet for this study

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

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 & Collaborators

  • Pharmacosmos A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-05-31
Completion
2012-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213979 on ClinicalTrials.gov