Relative bioavailability study of 20-mg enalapril tablets in healthy male volunteers.

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dc.contributor.authorLohitnavy, Ornraten_US
dc.contributor.authorLohitnavy, Manupaten_US
dc.contributor.authorPolnok, Sanglaren_US
dc.contributor.authorTaytiwat, Prawiten_US
dc.date.accessioned2009-05-27T18:13:08Z
dc.date.available2009-05-27T18:13:08Z
dc.date.issued2003-10-03en_US
dc.descriptionChotmaihet Thangphaet.en_US
dc.description.abstractThe pharmacokinetic and relative bioavailability studies of 20-mg enalapril tablets, the test product manufactured by Biolab, Thailand compared to the reference product (Merck Sharp & Dohme, USA) was conducted in 14 healthy Thai male volunteers following a single dose, two-period, crossover design. Each subject received 20-mg enalapril tablets of both formulations with a 1-week washout period. Plasma samples collected over a 24-h 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 (test/reference) of enalapril were 101.8-134.9 per cent and 105.9-121.4 per cent and those of enalaprilat were 104.2-122.3 per cent and 104.5-118.1 per cent. Based on the European bioequivalence guideline, the 90 per cent confidence intervals of Cmax and AUC(0-infinity) ratios of both parent and metabolite forms were within the acceptable ranges of 70-143 per cent and 80-125 per cent, respectively. It was concluded that the test formulation was bioequivalent to the reference formulation and both formulations can be used interchangeably in clinical practice.en_US
dc.description.affiliationBioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok 65000, Thailand.en_US
dc.identifier.citationLohitnavy O, Lohitnavy M, Polnok S, Taytiwat P. Relative bioavailability study of 20-mg enalapril tablets in healthy male volunteers. Journal of the Medical Association of Thailand. 2003 Oct; 86(10): 947-52en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/38699
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.meshAntihypertensive Agents --pharmacokineticsen_US
dc.subject.meshBiological Availabilityen_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshEnalapril --pharmacokineticsen_US
dc.subject.meshEnalaprilat --pharmacokineticsen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshVoluntary Workersen_US
dc.titleRelative bioavailability study of 20-mg enalapril tablets in healthy male volunteers.en_US
dc.typeClinical Trialen_US
dc.typeComparative Studyen_US
dc.typeJournal Articleen_US
dc.typeRandomized Controlled Trialen_US
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