Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia
NCT ID: NCT02170311
Last Updated: 2015-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-06-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Z-213 100mg
Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.
Z-213
Z-213 500mg
Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.
Z-213
Z-213 800mg
Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.
Z-213
Z-213 1000mg
Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.
Z-213
Interventions
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Z-213
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
* Patients with liver, kidney or circulatory system disease
* Patients with a history or present illness that is a malignant tumor or autoimmune disease
* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
18 Years
64 Years
ALL
No
Sponsors
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Zeria Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Zeria Investigator
Role: STUDY_DIRECTOR
Zeria Pharmaceutical Co., Ltd
Locations
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Zeria Investigative Site
Tokyo, , Japan
Countries
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Other Identifiers
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Z213-01
Identifier Type: -
Identifier Source: org_study_id
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