Bioequivalence of 2 Kinds of Omeprazole Enteric-coated Capsules in Healthy Volunteers

OBJECTIVE:To evaluate the bioequivalence of 2 kinds of omeprazole enteric-coated capsules in healthy volunteers.METHODS:A total of 20 healthy male volunteers were divided randomly into two groups,administered with two preparations of omeprazole respectively in an open randomized cross-over test.A single oral dose of the test and reference preparation was 40mg for each alternative.The omeprazole concentrations in the serum were determined by HPLC and the pharmacokinetic parameters and relative bioavailability were obtained by using DAS software.RESULTS:The pharmacokinetic parameters of the test and reference preparation were as follows:t1/2 were(1.685±0.866)h and(1.653±0.862)h;tmax were(2.425±0.693)h and(2.200±0.865)h;Cmax were(0.894±0.481)μg·mL-1 and (0.865±0.342)μg·mL-1;AUC0～10 were(2.041±1.446)μg·h·mL-1 and (2.022±1.322)μg·h·mL-1;AUC0～∞ were(2.163±1.594)μg·h·mL-1 and (2.125±1.507)μg·h·mL-1,respectively.The relative bioavailability of the test preparation was(100.3±17.4)%.CONCLUSION:The two formulations of omeprazole enteric-coated capsules are bioequivalent.