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

Boryung

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Essential Hypertension

Treatments: Drug: fimasartan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01146938

A657-BR-CT-112

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: Male

Ages: 20 to 64 years old

Volunteers: Accepts 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

Trial design

18 participants in 2 patient groups

hepatic impairment patients

Experimental group

Description:

Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C)

Treatment:

Drug: fimasartan

Drug: fimasartan

Healthy volunteers

Active Comparator group

Description:

healthy volunteers group

Treatment:

Drug: fimasartan

Drug: fimasartan