A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy Volunteers

To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers

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

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