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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146938
• Other study ID #: A657-BR-CT-112
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2010
• Last updated: January 2, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2010
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Essential Hypertension
• Hepatic Impairment
• Hypertension
• Liver Diseases

Intervention

Drug:
• fimasartan
single administration of fimasartan 120mg
• fimasartan
single administration of fimasartan 120mg

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd	Kyungpook National University, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic characteristics of fimasartan	AUC, Cmax, Tmax, T1/2, CL/F of fimasartan	0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h	Yes