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Original ArticleOpen Access
Bioequivalence Study of Enalapril Tablets in Healthy Thai Male Volunteers
Lohitnavy O 
,
Lohitnavy M ,
Taytiwat P ,
Polnok S
,
Lohitnavy M ,
Taytiwat P ,
Polnok S MANUPAT LOHITNAVY, M.S.*,
SANGLAR POLNOK, M.N.S.***
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 follow-
ing 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 deter-
mined by using non-compartmental analysis. Regarding bioequivalence testing, the 90 per cent con-
fidence 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 bio-
equivalent to Renitec 5 mg tablet.
Key word
: Bioequivalence, Enalapril, Enalaprilat
SANGLAR POLNOK, M.N.S.***
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 follow-
ing 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 deter-
mined by using non-compartmental analysis. Regarding bioequivalence testing, the 90 per cent con-
fidence 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 bio-
equivalent to Renitec 5 mg tablet.
Key word
: Bioequivalence, Enalapril, Enalaprilat
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