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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148368

Enrollment

Registered

2010-06-22

Start date

2010-06-30

Completion date

2011-07-31

Last updated

2012-01-09

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

Conditions

Renal Impairment

Keywords

fimasartan, renal impairment, hypertension

Brief summary

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal 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

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

\<Renal impairment patient\> * age: 20-65 years * eGFR: \< 30ml/min/1.73m\^2 * not on dialysis * body weight: greater than 55kg * written informed consent \<Healthy volunteer\> * age: 20-65 years * body weight: greater than 55kg * written informed consent

Exclusion criteria

* AST, ALT \> 1.5 times of upper normal range * positive drug or alcohol screening

Design outcomes

Primary

Measure	Time frame	Description
pharmacokinetic characteristic of fimasartan	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h	AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan

Countries

South Korea

Outcome results

None listed

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