Pharmacokinetic interactions of esaxerenone with amlodipine and digoxin in healthy Japanese subjects.

ABSTRACT:

Background

To investigate the effects of coadministration of esaxerenone with amlodipine on the pharmacokinetics (PK) of each drug, and of esaxerenone on the PK of digoxin.

Methods

In three open-label, single-sequence, crossover studies, healthy Japanese males received single oral doses of esaxerenone 2.5 mg (Days 1, 15), with amlodipine 10 mg/day (Days 8-18) (Study 1, N = 24); single doses of amlodipine 2.5 mg (Days 1, 21), with esaxerenone 5 mg/day (Days 8-25) (Study 2; N = 20); or digoxin 0.25 mg/day (Days 1-15) with esaxerenone 5 mg/day (Days 11-15) (Study 3; N = 20). PK parameters and safety were assessed.

Results

Study 1: esaxerenone peak plasma concentration (C_max) and time to C_max were unaltered by amlodipine coadministration, but mean ha

SUBMITTER: Kirigaya Y 

PROVIDER: S-EPMC7389645 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature