Lack of Clinical Relevance of Bilastine-Food Interaction in Healthy Volunteers: A Wheal and Flare Study.

ABSTRACT:

Introduction

The aim of this study was to compare the pharmacodynamic activity of bilastine administered under fasting and fed conditions in healthy volunteers.

Methods

In this randomized, open-label, two-period, crossover study involving 24 healthy subjects, once-daily oral bilastine 20 mg was administered for 4 days under fasting and fed conditions, with a 7-day washout period. Bilastine plasma concentrations were measured for 24 h after the first and fourth doses in each period. Pharmacodynamic activity was assessed by wheal and flare surface inhibition and subjective assessment of itching, after intradermal injection of histamine 5 μg.

Results

When administered under fed versus fasting conditions, exposure to bilastine 20 mg decreased (mean maximum plasma concentr

SUBMITTER: Coimbra J 

PROVIDER: S-EPMC9808715 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature