Bioequivalence of Omeprazole Enteric-coated Capsules in Chinese Healthy Volunteers

Objective To study the relative bioavailability and bioequivalence of omeprazole Enteric-coated capsules in healthy volunteers. Methods A single oral dose(40 mg of tested and reference formulation) was given to 20 healthy volunteers in a randomised crossover study,with one week dose interval.The plasma omeprazole concentrationswas determined within 12 h administration by HPLC.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program.AUC(0-12),AUC(0-inf) and Cmax was analysed by ANOVA followed by test,tmax was analysed by rank sum test. Results After a single dose administration,the pharmacokinetics parameters for omeprazole were as follows: Cmax were(939.63±284.29) μg·L-1 and(1 012.88±315.68) μg·L-1;tmax were(2.58±0.65) and(2.45±0.48) h;AUC(0-12) were(3 857.43±1 146.46) and(4 091.39±1 175.82) μg·h·L-1;AUC(0-inf) were(4 088.97±1 253.34)and(4 387.24±1 290.20) μg·h·L-1 for T and R respectively.The 90% confidential interval of Cmax,AUC(0-12) and AUC(0-inf) of tested formulation were 86.0%～101.7%,88.9%～101.5% and 87.3%～100.9% respectively. Conclusion The relative bioavailability of the tested and reference formulations was(96.26±16.52)%;The statistic analysis shows that the two formulations were bioequivalence.