{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T06:52:11Z","timestamp":1770965531670,"version":"3.50.1"},"reference-count":37,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2006,1,3]],"date-time":"2006-01-03T00:00:00Z","timestamp":1136246400000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Human Psychopharmacology"],"published-print":{"date-parts":[[2006,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The Central Nervous System (CNS) impairment induced by moderate alcohol (ALC) ingestion may be enhanced if other drugs are taken simultaneously. Rupatadine (RUP) is a new H<jats:sub>1<\/jats:sub>\u2010antihistamine which also inhibits platelet activating factor (PAF) release in inflammatory reactions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>The main aim of the study was to assess the effects of ALC 0.8\u2009g\/Kg on RUP (10\u2009mg and 20\u2009mg) CNS effects. An evaluation of alcohol and RUP pharmacokinetics was also attained.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eighteen healthy young volunteers of both sexes participated in a phase I, randomised, crossover, double\u2010blind, placebo\u2010controlled study. At 2\u2010week intervals they received six treatments: (a) placebo (PLA), (b) ALC alone and ALC in combination with: (c) hydroxyzine 25\u2009mg (HYD), (d) cetirizine 10\u2009mg (CET), (e) RUP 10\u2009mg or (f) RUP 20\u2009mg. At baseline and several times thereafter, seven psychomotor performance tests (finger tapping, fine motoric skills, nystagmus, temporal estimation, critical\u2010flicker\u2010fusion frequency, \u2018d2\u2019 cancellation, simple reaction) and eleven subjective self\u2010reports (drunkenness, sleepiness, alertness, clumsiness, anger, inattentiveness, efficiency, happiness, hostility, interest and extraversion) were carried out. Two\u2010way (treatment, time) ANOVAs for repeated measures to each variable together with a multivariate non\u2010parametric approach were applied. Plasma concentrations of alcohol, and of RUP and its metabolites, were quantified by validated immunofluorescence and LC\/MS\/MS methods, respectively. Plasma\u2010time curves for all compounds were analysed by means of model\u2010independent methods.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The combination of alcohol with HYD, CET and RUP 20\u2009mg produced more cognitive and psychomotor impairment as compared to alcohol alone, being the combination of alcohol and HYD the one which induced the greatest deterioration. The combination of alcohol and RUP 10\u2009mg could not be differentiated from ALC alone. Subjective self\u2010reports reflect effects on metacognition after the combination of alcohol with HYD and CET i.e. the increased objective impairment observed was not subjectively perceived by the subjects. No significant differences were obtained when comparing alcohol plasma concentrations assessed after the treatments evaluated. RUP showed a lineal kinetic relationship after 10 and 20\u2009mg with a higher exposition to both metabolites assayed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Present results showed that single oral doses of rupatadine 10\u2009mg in combination with alcohol do not produce more cognitive and psychomotor impairment than alcohol alone. Higher doses of rupatadine, in combination with alcohol, may induce cognitive and psychomotor deterioration as hydroxyzine and cetirizine at therapeutic doses. Copyright \u00a9 2006 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/hup.741","type":"journal-article","created":{"date-parts":[[2006,1,3]],"date-time":"2006-01-03T12:16:53Z","timestamp":1136290613000},"page":"13-26","source":"Crossref","is-referenced-by-count":44,"title":["Evaluation of the cognitive, psychomotor and pharmacokinetic profiles of rupatadine, hydroxyzine and cetirizine, in combination with alcohol, in healthy volunteers"],"prefix":"10.1002","volume":"21","author":[{"given":"Manuel J.","family":"Barbanoj","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Consuelo","family":"Garc\u00eda\u2010Gea","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa","family":"Antonijoan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I\u00f1aki","family":"Izquierdo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ester","family":"Donado","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I\u00f1aki","family":"P\u00e9rez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Solans","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesc","family":"Jan\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2006,1,3]]},"reference":[{"key":"e_1_2_1_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1995.tb04562.x"},{"key":"e_1_2_1_3_1","unstructured":"BarbanojMJ.1991.Efecto sobre el SNC de los ansiol\u00edticos en el hombre. 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