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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Kyungpook National University; Kyungpook National University Hospital; Yonsei University

Criteria

Inclusion Criteria:

• age: 20 - 64 years

• sex: male

• Child-Pugh score A or Child-Pugh score B

• body weight: greater than 55 kg

• written informed consent

• age: 20 - 64 years

• sex: male

• body weight: greater than 55 kg

• written informed consent

Exclusion Criteria:

• portosystemic shunt surgery

• Child-Pugh score C

• creatinine clearance < 80mL/min

• ascites

• 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