A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers
- Registration Number
- NCT01146938
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
<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
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Exclusion Criteria
<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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hepatic impairment patients fimasartan Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C) Healthy volunteers fimasartan healthy volunteers group
- Primary Outcome Measures
Name Time Method Pharmacokinetic characteristics of fimasartan 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h AUC, Cmax, Tmax, T1/2, CL/F of fimasartan
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of