Bioequivalence study of enalapril tablets in healthy Thai male volunteers.

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dc.contributor.authorLohitnavy, Ornraten_US
dc.contributor.authorLohitnavy, Manupaten_US
dc.contributor.authorTaytiwat, Prawiten_US
dc.contributor.authorPolnok, Sanglaren_US
dc.date.accessioned2009-05-27T19:45:39Z
dc.date.available2009-05-27T19:45:39Z
dc.date.issued2002-06-27en_US
dc.descriptionChotmaihet Thangphaet.en_US
dc.description.abstractThe bioequivalence study of 5-mg enalapril tablets, Enaril (Biolab, Thailand) compared to Renitec (Merck Sharp & Dohme, USA) was conducted in 14 healthy Thai male volunteers following a single dose, two-period, crossover design. Each subject received 4 tablets of 5-mg enalapril tablets of both formulations with a 1-week washout period. Plasma samples collected over a 24-hour period after administration were analyzed by LC/MS/MS. Pharmacokinetic parameters were determined by using non-compartmental analysis. Regarding bioequivalence testing, the 90 per cent confidence intervals of Cmax and AUC(0-infinity) ratios (Enaril/Renitec) of enalapril were 86.3-126.1 per cent and 93.0-118.5 per cent and those of enalaprilat were 86.4-124.1 per cent and 90.3-116.8 per cent. Based on the European bioequivalence guideline, the 90 per cent confidence interval of Cmax and AUC(0-infinity) ratios of both parent and metabolite forms were within acceptable ranges of 70-143 per cent and 80-125 per cent, respectively. It was concluded that Enaril 5 mg tablet was bioequivalent to Renitec 5 mg tablet.en_US
dc.description.affiliationBioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.en_US
dc.identifier.citationLohitnavy O, Lohitnavy M, Taytiwat P, Polnok S. Bioequivalence study of enalapril tablets in healthy Thai male volunteers. Journal of the Medical Association of Thailand. 2002 Jun; 85(6): 716-21en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/41737
dc.language.isoengen_US
dc.source.urihttps://www.mat.or.th/journal/all.phpen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAngiotensin-Converting Enzyme Inhibitors --administration & dosageen_US
dc.subject.meshConfidence Intervalsen_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshEnalapril --administration & dosageen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshThailanden_US
dc.subject.meshTherapeutic Equivalencyen_US
dc.titleBioequivalence study of enalapril tablets in healthy Thai male volunteers.en_US
dc.typeClinical Trialen_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
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