Relative Bioavailability Study of 20-mg Enalapril Tablets
in Healthy Male Volunteers
ORNRAT LOHITNAVY,MSc*, MANUPAT LOHITNAVY,MS*,
SANGLAR POLNOK, MNS**, PRAWIT TAYTIWAT, MD***
Affiliation : * Bioequivalence Test Center, Faculty of Pharmaceutical Sciences,
**Faculty of Nursing,
***Health Sciences Research Institute, Naresuan University, Phitsanulok 65000, Thailand.
AbstractThe 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 AUC0_~ 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 AUC0_~ 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.
Keywords : Enalapril, Enalaprilat, Pharmacokinetics, Bioequivalence, Relative Bioavailability
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