The effect of hepatic or renal impairment on the pharmacokinetics of edivoxetine, a selective norepinephrine transporter reuptake inhibitor.

ABSTRACT:

Purpose

To assess the impact of hepatic or renal impairment on the pharmacokinetics (PK) of edivoxetine.

Methods

Two separate multi-center, open-label studies with males and females were conducted. Subjects were categorized according to their hepatic function, determined by the Child-Pugh classification, or renal function, determined by creatinine clearance using the Cockcroft-Gault equation. Subjects received a single dose of 18 mg in the hepatic impairment study or 6 mg in the renal impairment study. Noncompartmental PK parameters were computed from the edivoxetine plasma concentration-time data.

Results

In the hepatic study, the geometric least squares mean (GLSM) and 90 % confidence interval (CI) of the ratio [impaired : normal] of area under the concentration ver

SUBMITTER: Kielbasa W 

PROVIDER: S-EPMC3832778 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature