{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,5,1]],"date-time":"2023-05-01T20:10:54Z","timestamp":1682971854251},"reference-count":0,"publisher":"Weston Medical Publishing","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J of Opioid Management"],"abstract":"<jats:p>Objectives: To assess the single-dose and steady-state pharmacokinetics of a single-entity hydrocodone extended-release (ER) formulation in patients enrolled in two separate phase 2 clinical studies.Setting: Both studies were multicenter clinical studies.Subjects and interventions: In study 1, 115 subjects with postsurgical pain (bunionectomy) received single doses of 10, 20, 30, or 40 mg hydrocodone-ER, 10 mg hydrocodone\/325 mg acetaminophen immediate-release (IR), or placebo. In study 2, 37 subjects with osteoarthritic pain received doses of 10, 20, 30, or 40 mg of hydrocodone-ER twice-daily for 7 days. Venous blood samples were taken periodically up to 24 hours postdosing after the single dose (study 1) or after 7 days of dosing (study 2) and were assayed for concentrations of hydrocodone and its major metabolites.Main outcome measures: Standard pharmacokinetic parameters were estimated by noncompartmental analysis methods.Results: Following a single dose of hydrocodone-ER, Tmax was prolonged to approximately 6 hours at all dose levels of hydrocodone-ER compared with 2.9 hours for the IR formulation. All doses of hydrocodone-ER formulations provided prolonged and sustained release of hydrocodone throughout the 12-hour dosing interval with reduced peak-to-trough fluctuation at steady state compared with hydrocodone\/acetaminophen-IR comparator. Both single-dose and steady-state mean Cmax and AUClast values showed reasonable dose-proportionality. Norhydrocodone and hydromorphone plasma concentrations were 32-38 percent and &lt;2.1 percent, respectively, of hydrocodone concentrations in both studies.Conclusions: The sustained plasma concentrations of hydrocodone support twice-daily dosing with a 12-hour dosing interval.<\/jats:p>","DOI":"10.5055\/jom.2015.0290","type":"journal-article","created":{"date-parts":[[2015,11,5]],"date-time":"2015-11-05T15:00:54Z","timestamp":1446735654000},"page":"405-415","source":"Crossref","is-referenced-by-count":3,"title":["A pharmacokinetic evaluation of single and multiple doses of extended-release hydrocodone bitartrate in subjects experiencing surgical or osteoarthritic pain"],"prefix":"10.5055","volume":"11","author":[{"given":"Cynthia Y.","family":"Robinson, PhD","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher M.","family":"Rubino, PharmD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen J.","family":"Farr, PhD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3008","published-online":{"date-parts":[[2015,9,1]]},"container-title":["Journal of Opioid Management"],"original-title":[],"link":[{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/download\/218\/194","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/download\/218\/194","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,1]],"date-time":"2023-05-01T19:48:14Z","timestamp":1682970494000},"score":1,"resource":{"primary":{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/view\/218"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,9,1]]},"references-count":0,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2015,9,1]]}},"URL":"https:\/\/doi.org\/10.5055\/jom.2015.0290","relation":{},"ISSN":["1551-7489","1551-7489"],"issn-type":[{"value":"1551-7489","type":"electronic"},{"value":"1551-7489","type":"print"}],"subject":[],"published":{"date-parts":[[2015,9,1]]}}}