Pharmacokinetic Profile and Palatability of Atomoxetine Oral Solution in Healthy Japanese Male Adults.

ABSTRACT:

Background and objectives

There is a clinical need for a liquid formulation of atomoxetine. We assessed the safety and bioequivalence of an atomoxetine oral solution.

Methods

This was an open-label, randomized, crossover study. Healthy adult male Japanese subjects (n = 42) with a cytochrome P450 2D6 extensive (including intermediate and ultrarapid) metabolizer genotype were administered atomoxetine 50 mg as oral solution and capsules once each, with a washout period >5 days between doses. Blood samples were used to analyze pharmacokinetic parameters, particularly maximum observed drug concentration (C _max) and area under the concentration vs. time curve from time zero to the last time point with a measurable concentration (AUC_0-last). Bioequivalence was

SUBMITTER: Nakano M 

PROVIDER: S-EPMC5073111 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature