{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T19:32:39Z","timestamp":1740166359561,"version":"3.37.3"},"reference-count":12,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2014,12,22]],"date-time":"2014-12-22T00:00:00Z","timestamp":1419206400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2015,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>In these combined analyzes from 3 open\u2010label, phase\u20101 studies, the pharmacokinetic profile of tramadol and its metabolite (M1) following administration of tramadol immediate\u2010release (IR) tablets in children and adolescents, 7\u201316 years old (studies 1 and 2: n\u2009=\u200938; study 3: n\u2009=\u200921) with painful conditions following single oral dose of tramadol IR (25\u2013100\u2009mg) (studies 1 and 2) or multiple oral doses of tramadol IR tablets every 6\u2009hours for 3 days (study 3) were compared with that of healthy adults following similar treatment. Area under the curve of tramadol and its metabolite M1 in children and adolescents was lower compared with adults (Dose\u2010normalized [DN] AUC, h\u2009ng\/mL: tramadol: 1316.87 [children]; 1418.02 [adolescents];1838.29 [adults]; M1: 342.56 [children]; 475.4 [adolescents]; 636.13 [adults]) while the C<jats:sub>max<\/jats:sub> remained similar (DN\u2009C<jats:sub>max<\/jats:sub>, ng\/mL: tramadol: 203.75 [children]; 165.35 [adolescents]; 226.92 [adults]; M1: 34.93 [children]; 38.42 [adolescents]; 52.14 [adults]). The DN AUC was further lower in children and adolescents with a lower body weight (&lt;50\u2009kg). The weight normalized oral clearance of tramadol was higher in children and adolescents compared with adults (CL\/F, mL\/min\/kg: 12.66 [children]; 11.75 [adolescents]; 9.06 [adults]). No new safety findings emerged. Tramadol was generally safe and well\u2010tolerated by children and adolescents with painful conditions.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cpdd.169","type":"journal-article","created":{"date-parts":[[2014,11,5]],"date-time":"2014-11-05T11:14:07Z","timestamp":1415186047000},"page":"184-192","source":"Crossref","is-referenced-by-count":11,"title":["Single\u2010 and multiple\u2010dose pharmacokinetic studies of tramadol immediate\u2010release tablets in children and adolescents"],"prefix":"10.1002","volume":"4","author":[{"given":"J.","family":"Vandenbossche","sequence":"first","affiliation":[{"name":"Janssen Research &amp; Development Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H.","family":"Richards","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Solanki","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Van Peer","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Beerse Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,12,22]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"Schedules of Controlled Substances: Placement of Tramadol into Schedule IV Background Data and Analysis: Eight Factors Determinative of Control and Findings Pursuant to 21 U.S.C. 812(b) United States Department of Justice Drug Enforcement Administration. Office of Diversion Control Drug and Chemical Evaluation Section Washington D.C. May 2013."},{"key":"e_1_2_12_3_1","unstructured":"KayeK TheakerN TRAMADOL A Position Statement of the NSW Therapeutic Assessment Group Inc. September 2001http:\/\/www.ciap.health.nsw.gov.au\/nswtag\/documents\/publications\/position\u2010statements\/archive\u2010tramadol\u2010sept\u20102001.pdf."},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.bja.a013437"},{"issue":"4","key":"e_1_2_12_5_1","first-page":"109","article-title":"Pharmacokinetics of oral tramadol drops for postoperative pain relief in children aged 4 to 7 years\u2013a pilot study","volume":"49","author":"Payne KA","year":"2002","journal-title":"Anesth Prog"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270009347673"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200443130-00004"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1213\/00000539-200206000-00017"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000539-200301000-00016"},{"key":"e_1_2_12_10_1","first-page":"308","article-title":"Pharmacokinetics of tramadol following single and multiple oral doses in man [abstract]","volume":"9","author":"Liao S","year":"1992","journal-title":"Pharm Res"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-006-9049-7"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aeh178"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2007.01.001"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.169","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.169","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T06:51:48Z","timestamp":1696575108000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.169"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,12,22]]},"references-count":12,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2015,3]]}},"alternative-id":["10.1002\/cpdd.169"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.169","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"type":"print","value":"2160-763X"},{"type":"electronic","value":"2160-7648"}],"subject":[],"published":{"date-parts":[[2014,12,22]]}}}