Bioequivalence study of ondansetron tablet in healthy Thai male volunteers.

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dc.contributor.authorLohitnavy, Manupaten_US
dc.contributor.authorChaijittiprasert, Kasineeen_US
dc.contributor.authorPolnok, Sanglaren_US
dc.contributor.authorLohitnavy, Ornraten_US
dc.contributor.authorTaytiwat, Prawiten_US
dc.date.accessioned2009-05-27T21:43:22Z
dc.date.available2009-05-27T21:43:22Z
dc.date.issued2002-07-26en_US
dc.descriptionChotmaihet Thangphaet.en_US
dc.description.abstractOBJECTIVES: To assess the average bioequivalence of two formulations of 8-mg ondansetron tablets--test product (Unison Laboratories, Thailand) and reference product (Glaxo Wellcome, USA)--in 14 healthy Thai male volunteers. MATERIAL AND METHOD: In a randomized, single dose, fasting, two-period, crossover study design with a 1-week washout period, each subject received an 8-mg ondansetron tablet. Serum samples were collected over a 24-hour period after administration. Subsequently serum concentrations of ondansetron were analyzed by using a validated HPLC-UV method. Pharmacokinetic parameters were determined by using non-compartmental analysis. RESULTS: No significant difference was observed in any of the pharmacokinetic parameters analyzed. The time to reach the maximal concentration (Tmax, hour), the peak concentration (Cmax, ng/ ml) and the area under the concentration-time curve (AUC(0-infinity), ng x h/ml) of ondansetron for reference and test preparations were 2.6 + 1.8 vs 2.2 + 0.6, 49.5 +/- 18.9 vs 48.5 +/- 13.7 and 352.2 +/- 184.7 vs 323.8 +/- 154.5, respectively. The 90 per cent confidence intervals for Test/Reference ratio of Cmax and AUC(0-infinity) were found within the bioequivalence range of 80-125 per cent (90.3-110.0% and 88.4-99.6%, respectively). CONCLUSION: The bioequivalence of these two ondansetron preparations was demonstrated.en_US
dc.description.affiliationBioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.en_US
dc.identifier.citationLohitnavy M, Chaijittiprasert K, Polnok S, Lohitnavy O, Taytiwat P. Bioequivalence study of ondansetron tablet in healthy Thai male volunteers. Journal of the Medical Association of Thailand. 2002 Jul; 85(7): 808-13en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/45288
dc.language.isoengen_US
dc.source.urihttps://www.mat.or.th/journal/all.phpen_US
dc.subject.meshAdministration, Oralen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAntiemetics --administration & dosageen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshOndansetron --administration & dosageen_US
dc.subject.meshReference Valuesen_US
dc.subject.meshTabletsen_US
dc.subject.meshThailanden_US
dc.subject.meshTherapeutic Equivalencyen_US
dc.titleBioequivalence study of ondansetron tablet in healthy Thai male volunteers.en_US
dc.typeClinical Trialen_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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