{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T22:55:40Z","timestamp":1763765740340},"reference-count":24,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2008,10,23]],"date-time":"2008-10-23T00:00:00Z","timestamp":1224720000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2009,2]]},"abstract":"<jats:sec><jats:label \/><jats:p> <jats:bold>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT<\/jats:bold> <\/jats:p><jats:p>\u2022\u2003Rotigotine transdermal patch is a new non\u2010ergolinic dopamine agonist developed for the treatment of Parkinson's disease and restless legs syndrome.<\/jats:p><jats:p>\u2022\u2003Peripheral dopaminergic side\u2010effects of dopamine agonists such as nausea and vomiting can be prevented by the antiemetic agent domperidone.<\/jats:p><jats:p> <jats:bold>WHAT THIS STUDY ADDS<\/jats:bold> <\/jats:p><jats:p>\u2022\u2003The study results show no evidence for an interaction of domperidone on bioavailability and steady\u2010state pharmacokinetics of transdermal rotigotine.<\/jats:p><jats:p>\u2022\u2003Co\u2010administration of domperidone and rotigotine does not require dose adjustments for rotigotine transdermal patch.<\/jats:p><\/jats:sec><jats:sec><jats:title>AIMS<\/jats:title><jats:p>To evaluate the influence of the antiemetic agent domperidone on steady\u2010state pharmacokinetics, safety and tolerability of multiple\u2010dose treatment of the transdermally applied non\u2010ergolinic dopamine agonist rotigotine.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Sixteen healthy male subjects (mean age 30.3 years) participated in a randomized, two\u2010way crossover clinical trial. Treatment A consisted of transdermal rotigotine patch (2\u2003mg\u2003(24\u2003h)<jats:sup>\u22121<\/jats:sup>, 10\u2003cm<jats:sup>2<\/jats:sup>, total drug content 4.5\u2003mg) applied daily for 4\u2003days, and concomitant oral domperidone (10\u2003mg t.i.d.) for 5\u2003days. For treatment B, subjects received only transdermal rotigotine treatment (daily for 4\u2003days). Pharmacokinetic variables describing systemic exposure and renal elimination of rotigotine and metabolites, and safety and tolerability of the treatment were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The primary steady\u2010state pharmacokinetic parameters (<jats:italic>C<\/jats:italic><jats:sub>max,ss<\/jats:sub> and AUC<jats:sub>(0\u201324),ss<\/jats:sub>) were similar with or without co\u2010administration of domperidone. Geometric mean ratios were close to 1 and respective 90% confidence intervals were within the acceptance range of bioequivalence (0.8, 1.25): <jats:italic>C<\/jats:italic><jats:sub>max,ss<\/jats:sub> 0.96 (0.86, 1.08) and AUC<jats:sub>(0\u201324),ss<\/jats:sub> 0.97 (0.87, 1.08). <jats:italic>t<\/jats:italic><jats:sub>max,ss<\/jats:sub>, <jats:italic>t<\/jats:italic><jats:sub>1\/2<\/jats:sub>, secondary parameters calculated on days 4\/5 after repeated patch application (<jats:italic>C<\/jats:italic><jats:sub>min,ss<\/jats:sub>, <jats:italic>C<\/jats:italic><jats:sub>ave,ss<\/jats:sub>, AUC<jats:sub>(0\u2013tz)<\/jats:sub>) and renal elimination for unconjugated rotigotine and its metabolites were also similar with and without comedication of domperidone. A reduction in the dopaminergic side\u2010effect nausea was seen with domperidone comedication.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>No changes of pharmacokinetic parameters describing systemic exposure and renal elimination of rotigotine were observed when domperidone was administered concomitantly with rotigotine. The lack of pharmacokinetic interactions indicates that a dose adjustment of rotigotine transdermal patch is not necessary with concomitant use of domperidone.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1365-2125.2008.03334.x","type":"journal-article","created":{"date-parts":[[2008,12,19]],"date-time":"2008-12-19T00:04:14Z","timestamp":1229645054000},"page":"209-215","source":"Crossref","is-referenced-by-count":34,"title":["Influence of domperidone on pharmacokinetics, safety and tolerability of the dopamine agonist rotigotine"],"prefix":"10.1111","volume":"67","author":[{"given":"Marina","family":"Braun","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Willi","family":"Cawello","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hilmar","family":"Boekens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rolf","family":"Horstmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2009,2,23]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.65.2_suppl_1.S3"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.65.2_suppl_1.S6"},{"key":"e_1_2_6_4_2","unstructured":"Schwarz Pharma.Neupro\u00ae (Rotigotine Transdermal System). Available athttp:\/\/www.emea.europa.eu\/humandocs\/PDFs\/EPAR\/neupro\/H\u2010626\u2010PI\u2010en.pdf(last accessed 5 November 2008)."},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.65.2_suppl_1.S11"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.2165\/00023210-200519110-00006"},{"key":"e_1_2_6_7_2","first-page":"1091","article-title":"Low drug\u2013drug interaction potential of rotigotine","volume":"45","author":"Hansen K","year":"2005","journal-title":"J Clin Pharmacol"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252355.79284.22"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(07)70108-4"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2007.04.010"},{"key":"e_1_2_6_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(08)70112-1"},{"key":"e_1_2_6_12_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.18003"},{"key":"e_1_2_6_13_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-198224050-00002"},{"key":"e_1_2_6_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/00002826-198612000-00003"},{"key":"e_1_2_6_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF03189515"},{"key":"e_1_2_6_16_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2004.02156.x"},{"key":"e_1_2_6_17_2","unstructured":"Janssen\u2010Cilag.Motilium\u00ae domperidone. 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