Lohitnavy, OrnratLohitnavy, ManupatTaytiwat, PrawitPolnok, Sanglar2009-05-272009-05-272002-06-27Lohitnavy 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): 716-21http://imsear.searo.who.int/handle/123456789/41737Chotmaihet Thangphaet.The 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.engAdolescentAdultAngiotensin-Converting Enzyme Inhibitors --administration & dosageConfidence IntervalsCross-Over StudiesEnalapril --administration & dosageHumansMaleMiddle AgedThailandTherapeutic EquivalencyClinical Trial