A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers
NCT ID: NCT01148368
Last Updated: 2012-01-09
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
16 participants
INTERVENTIONAL
2010-06-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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renal impairment patients
renal impairment patients who eGFR is lower than 30 ml/min/1.73m\^2 without hemodialysis
fimasartan
single administration of fimasartan 120mg
healthy volunteers
healthy volunteers group
fimasartan
single administration of fimasartan 120mg
Interventions
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fimasartan
single administration of fimasartan 120mg
Eligibility Criteria
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Inclusion Criteria
* age: 20-65 years
* eGFR: \< 30ml/min/1.73m\^2
* not on dialysis
* body weight: greater than 55kg
* written informed consent
\<Healthy volunteer\>
* age: 20-65 years
* body weight: greater than 55kg
* written informed consent
Exclusion Criteria
* positive drug or alcohol screening
20 Years
65 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yon Su Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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A657-BR-CT-113
Identifier Type: -
Identifier Source: org_study_id
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