Pharmacokinetics and bioequivalence of omeprazole enteric-coated capsules in healthy volunteers

Objective:To investigate the bioequivalence of omeprazole enteric-coated capsules of two manufactories in Chinese healthy volunteers.Methods:Twenty volunteers were randomly divided into two groups(test and reference),with double cross-over design.The concentration of omeprazole in serum was determined by high performance liquid chromatography(HPLC)and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results:The pharmacokinetic parameters of the test and reference preparation were as follows:t1/2 were(1.789±0.862)h and(1.499±0.503)h;Cmax were(0.506±0.25)μg/ml and(0.493±0.195)μg/ml,Tmax were(2.050±0.642)h and(2.038±0.630)h,AUC0-12 h were(1.640±1.408)μg·h-1·ml-1 and(1.570±0.997)μg·h-1·ml-1,respectively.The relative bioavalibility of the test peparation was(101.48±33.82)%.Conclusions:The statistical analysis showed that the test and reference preparations were bioequivalent.