The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study.

ABSTRACT:

Background

This was an open-label, phase I, nonrandomized, single-sequence, crossover study to evaluate the effect of concomitant administration of multiple doses of clarithromycin on the single-dose exposure, safety, and tolerability of apixaban in healthy subjects.

Methods

In total, 19 subjects received a single oral dose of apixaban 10 mg on day 1. On day 4, subjects began receiving oral clarithromycin immediate release (IR) 500 mg twice daily (bid) for 4 days. On day 8, subjects received oral apixaban 10 mg and oral clarithromycin IR 500 mg bid. Oral clarithromycin IR 500 mg bid was given alone on days 9 and 10.

Results

Compared with apixaban alone, coadministration of apixaban with clarithromycin resulted in increased apixaban exposure. The adjusted geometric mea

SUBMITTER: Garonzik S 

PROVIDER: S-EPMC6885504 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature