Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)
NCT03013439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-12-12
Summary
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
Conditions
- Anemia
- Deficiency Diseases
- Anemia, Iron Deficiency
- Hematologic Disease
- Iron Metabolism Disorders
Interventions
- DRUG
-
Iron Isomaltoside
The trial is a dose escalating trial.
Sponsors & Collaborators
-
Pharmacosmos A/S
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-06
- Primary Completion
- 2017-06-04
- Completion
- 2017-06-04
Countries
- Japan
Study Locations
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