A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
1 other identifier
interventional
18
1 country
1
Brief Summary
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedJanuary 5, 2012
December 1, 2010
9 months
June 17, 2010
January 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic characteristics of fimasartan
AUC, Cmax, Tmax, T1/2, CL/F of fimasartan
0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h
Study Arms (2)
hepatic impairment patients
EXPERIMENTALHepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C)
Healthy volunteers
ACTIVE COMPARATORhealthy volunteers group
Interventions
Eligibility Criteria
You may qualify if:
- \<Hepatic impairment patient\>
- 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
You may not qualify if:
- \<Hepatic impairment patient\>
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boryung Pharmaceutical Co., Ltdlead
- Kyungpook National University Hospitalcollaborator
- Yonsei Universitycollaborator
Study Sites (1)
Severance Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 24084213DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Minsoo Park, PhD
Yonsei University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
January 5, 2012
Record last verified: 2010-12