A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
NCT ID: NCT01146938
Last Updated: 2012-01-05
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
18 participants
INTERVENTIONAL
2010-05-31
2011-02-28
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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hepatic impairment patients
Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C)
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
fimasartan
single administration of fimasartan 120mg
Eligibility Criteria
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Inclusion Criteria
* age: 20 - 64 years
* sex: male
* Child-Pugh score A or Child-Pugh score B
* body weight: greater than 55 kg
* written informed consent
\<Healthy volunteer\>
* age: 20 - 64 years
* sex: male
* body weight: greater than 55 kg
* written informed consent
Exclusion Criteria
* portosystemic shunt surgery
* Child-Pugh score C
* creatinine clearance \< 80mL/min
* ascites
\<Healthy volunteer\>
* AST(SGOT), ALT(SGPT) \> 1.5 times of Upper Normal Range
* Total bilirubin \> 1.5 times of Upper Normal Range
* positive drug or alcohol screening
20 Years
64 Years
MALE
Yes
Sponsors
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Kyungpook National University Hospital
OTHER
Yonsei University
OTHER
Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Minsoo Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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References
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Kim CO, Lee HW, Oh ES, Seong SJ, Kim DY, Lee J, Ahn SH, Yoon YR, Cho CM, Park MS. Influence of hepatic dysfunction on the pharmacokinetics and safety of fimasartan. J Cardiovasc Pharmacol. 2013 Dec;62(6):524-9. doi: 10.1097/FJC.0000000000000010.
Other Identifiers
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A657-BR-CT-112
Identifier Type: -
Identifier Source: org_study_id
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