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

Boryung Pharmaceutical Co., Ltd16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

fimasartanDRUG

single administration of fimasartan 120mg

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

pharmacokinetic characteristic of fimasartan

AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan

Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h

Data from ClinicalTrials.gov

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