Täubel, J; Ferber, G; Fernandes, S; Lorch, U; Santamaría, E; Izquierdo, I
(2016)
Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial.
PLoS One, 11 (9).
e0163020.
ISSN 1932-6203
https://doi.org/10.1371/journal.pone.0163020
SGUL Authors: Taubel, Jorg
Abstract
INTRODUCTION: Rupatadine is a marketed second generation antihistamine, with anti-PAF activity, indicated for symptomatic treatment of allergic rhinitis and urticaria. This study was conducted to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of rupatadine in healthy Japanese subjects after single and multiple oral doses. METHODS: In this randomised, double-blind, placebo-controlled study, 27 male and female healthy Japanese subjects were administered single and multiple escalating rupatadine dose of 10, 20 and 40 mg or placebo. Blood samples were collected at different time points for PK measurements and subjects were assessed for safety and tolerability. The effect of rupatadine on cognitive functioning was evaluated by means of computerized cognitive tests: rapid visual information processing (RVP), reaction time (RT), spatial working memory (SWM) and visual analogue scales (VAS). RESULTS: Exposure to rupatadine as measured by Cmax and AUC was found to increase in a dose dependent manner over the dose range of 10-40 mg for both single and multiple dose administration. The safety assessments showed that all treatment related side effects were of mild intensity and there were no serious adverse events (SAEs) or withdrawals due to treatment-emergent adverse events (TEAEs) in this study. The therapeutic dose of rupatadine did not show any CNS impairment in any of the cognitive tests. CONCLUSIONS: This study demonstrated that rupatadine is safe and well tolerated by Japanese healthy subjects. The PK-PD profile confirmed previous experience with rupatadine.
Item Type: |
Article
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Additional Information: |
Copyright: © 2016 Täubel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
Keywords: |
Adult, Area Under Curve, Cognition, Cyproheptadine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Healthy Volunteers, Histamine Antagonists, Humans, Japan, Male, Placebos, Platelet Activating Factor, Humans, Cyproheptadine, Platelet Activating Factor, Histamine Antagonists, Placebos, Area Under Curve, Double-Blind Method, Cognition, Dose-Response Relationship, Drug, Adult, Japan, Female, Male, Healthy Volunteers, General Science & Technology, MD Multidisciplinary |
SGUL Research Institute / Research Centre: |
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) |
Journal or Publication Title: |
PLoS One |
ISSN: |
1932-6203 |
Language: |
eng |
Dates: |
Date | Event |
---|
15 September 2016 | Published | 31 August 2016 | Accepted |
|
Publisher License: |
Creative Commons: Attribution 4.0 |
PubMed ID: |
27632557 |
Web of Science ID: |
WOS:000383706900118 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/114098 |
Publisher's version: |
https://doi.org/10.1371/journal.pone.0163020 |
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