Relative bioavailability study of 20-mg enalapril tablets in healthy male volunteers.
No Thumbnail Available
Date
2003-10-03
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
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 bioequivalence testing, the 90 per cent confidence intervals of Cmax and AUC(0-infinity) 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-infinity) ratios of both parent and metabolite forms were within 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 interchangeably in clinical practice.
Description
Chotmaihet Thangphaet.
Keywords
Citation
Lohitnavy O, Lohitnavy M, Polnok S, Taytiwat P. Relative bioavailability study of 20-mg enalapril tablets in healthy male volunteers. Journal of the Medical Association of Thailand. 2003 Oct; 86(10): 947-52