Bioequivalence study of enalapril tablets in healthy Thai male volunteers.
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.
D000293:Adolescent; D000328:Adult; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004656:Enalapril / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013785:Thailand; D013810:Therapeutic Equivalency
D000806:Angiotensin-Converting Enzyme Inhibitors; D004656:Enalapril