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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01146938

Enrollment

Registered

2010-06-22

Start date

2010-05-31

Completion date

2011-02-28

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension, Hepatic Impairment

Keywords

fimasartan, hepatic impairment

Brief summary

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

Interventions

DRUGfimasartan

single administration of fimasartan 120mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026