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

Boryung

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: fimasartan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01148368

A657-BR-CT-113

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

renal impairment patients

Experimental group

Description:

renal impairment patients who eGFR is lower than 30 ml/min/1.73m\^2 without hemodialysis

Treatment:

Drug: fimasartan

healthy volunteers

Active Comparator group

Description:

healthy volunteers group

Treatment:

Drug: fimasartan