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dc.contributor.authorRolan, P.
dc.contributor.authorLim, Stephen
dc.contributor.authorSunderland, Bruce
dc.contributor.authorLiu, Yandi
dc.contributor.authorMolnar, V.
dc.date.accessioned2017-01-30T12:47:46Z
dc.date.available2017-01-30T12:47:46Z
dc.date.created2014-06-17T20:00:15Z
dc.date.issued2014
dc.identifier.citationRolan, P. and Lim, S. and Sunderland, B. and Liu, Y. and Molnar, V. 2014. The absolute bioavailability of racemic ketamine from a novel sublingual formulation. British Journal of Clinical Pharmacology. 77 (6): pp. 1011-1016.
dc.identifier.urihttp://hdl.handle.net/20.500.11937/25299
dc.identifier.doi10.1111/bcp.12264
dc.description.abstract

AIM: The principal study objective was to investigate the pharmacokinetic characteristics of a new sublingual ketamine wafer and to establish its absolute bioavailability and local tolerability. METHODS: The study was of open label, two way randomized crossover design in eight healthy male volunteers. Each participant received either a single 10 mg intravenous dose as a constant rate 30 min infusion or a 25 mg sublingual dose of ketamine wafer in two treatment periods with a 7 day wash out. Pharmacokinetic blood sampling and local tolerability and safety assessments were carried out during 24 h following both dosing occasions. Plasma concentrations were analyzed by non-compartmental methods and local tolerability was assessed using modified Likert scales. RESULTS: The median (90% CI lower, upper limit) absolute bioavailability of sublingual ketamine was 29% (27, 31%). The first quantifiable plasma ketamine concentration was observed within 5 min for all eight participants for both routes of administration and the median (min–max) time of the peak plasma concentration was 0.75 h (0.25–1.0 h) after sublingual administration. The ketamine wafer had very good local tolerability. CONCLUSION: Sublingual administration of the ketamine wafer resulted in rapid absorption. The ketamine wafer has comparable bioavailability with other oral transmucosal formulations of ketamine but with markedly reduced inter-subject variability, warranting further evaluation as analgesic adjunct.

dc.publisherBlackwell Publishing
dc.subjectketamine
dc.subjectsublingual
dc.subjectbioavailability
dc.subjectpharmacokinetics
dc.titleThe absolute bioavailability of racemic ketamine from a novel sublingual formulation
dc.typeJournal Article
dcterms.source.volume77
dcterms.source.number6
dcterms.source.startPage1011
dcterms.source.endPage1016
dcterms.source.issn03065251
dcterms.source.titleBritish Journal of Clinical Pharmacology
curtin.departmentSchool of Pharmacy
curtin.accessStatusOpen access via publisher


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