Bioequivalence Study of Enalapril Tablets in Healthy Thai Male Volunteers

ORNRA T LOHITNA VY, M.Sc. MANUPAT LOHITNAVY, M.S.*, PRAWIT TAYTIWAT,M.D.**, SANGLAR POLNOK, M.N.S.***

Affiliation : * Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, ** Health Sciences Research Institute, *** Faculty of Nursing, Naresuan University, Phitsanulok 65000, Thailand.

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 !-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 em.. and AUC0-- 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 Cma* and AUC 0__ 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.

Keywords : Bioequivalence, Enalapril, Enalaprilat

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