Effect of renal function on the pharmacokinetics of fimasartan: a single-dose, open-label, Phase I study.

ABSTRACT:

Background

Fimasartan is a novel angiotensin II receptor blocker. Fimasartan is mainly eliminated via biliary excretion, and its urinary elimination is less than 3%.

Objective

Based on guidance from the United States Food and Drug Administration, a reduced pharmacokinetic (PK) study was conducted to evaluate the effect of renal function on the PK of fimasartan in patients with renal impairment and healthy volunteers.

Methods

A single centre, single-dose, open-label, healthy volunteer controlled trial was conducted in patients with renal impairment (RI) (estimated glomerular filtration rate lower than 30 mL/min/1.73 m(2)) and age-, weight- and sex-matched healthy volunteers (estimated glomerular filtration rate higher than 90 mL/min/1.73 m(2)). All participants receive

SUBMITTER: Kim S 

PROVIDER: S-EPMC4199969 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature