Views: 1,443 | Downloads:
33
| Responses: 0
| XML | Respond to this article | Alert & updates | Request permissions | Email to a friend |
Original ArticleOpen Access
Relative Bioavailability Study of 20-mg Enalapril Tablets in Healthy Male Volunteers
Lohitnavy O 
,
Lohitnavy M ,
Polnok M ,
Taytiwat P
,
Lohitnavy M ,
Polnok M ,
Taytiwat P MANUPAT LOHITNAVY,MS*,
PRAWIT TAYTIWAT, MD***
The 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 bio-
equivalence testing, the 90 per cent confidence intervals of Cmax and
AUC
0_~
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_~
ratios of both parent and metabolite forms were '>'.'ithin 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 inter-
changeably in clinical practice.
Key word : Enalapril, Enalaprilat, Pharmacokinetics, Bioequivalence, Relative Bioavailability
PRAWIT TAYTIWAT, MD***
The 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 bio-
equivalence testing, the 90 per cent confidence intervals of Cmax and
AUC
0_~
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_~
ratios of both parent and metabolite forms were '>'.'ithin 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 inter-
changeably in clinical practice.
Key word : Enalapril, Enalaprilat, Pharmacokinetics, Bioequivalence, Relative Bioavailability
Download:
PDF