Status:
COMPLETED
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Kyungpook National University Hospital
Yonsei University
Conditions:
Essential Hypertension
Hepatic Impairment
Eligibility:
MALE
20-64 years
Phase:
PHASE1
Brief Summary
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
Eligibility Criteria
Inclusion
- \<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
Exclusion
- \<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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01146938
Start Date
May 1 2010
End Date
February 1 2011
Last Update
January 5 2012
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea