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:t_1/2 were(1.789±0.862) h and(1.499±0.503) h;C_max were(0.506±0.25) μg/ml and(0.493±0.195) μg/ml,T_max were(2.050±0.642) h and(2.038±0.630) h,AUC_{0-12 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.