Clinical Studies Of Bioavailability And Bioequivalence In Lansoprazole

For emeasuring the serum concentrations of lansoprazole in healthy subjects, the HPLC method was used. Using the HPLC method, the results of method validation observed that the impurities of serum did not interfere with the determination of sample, and the linear range was0.028-2.80μg/ml, the lowest limit of quantitation was79.69%-94.73%, the RSD value of day and night were less than15%.This method meets the requirements of biological sample analysis.24healthy volunteers were randomly paired crossover trial of oral preparation of lansoprazole tablets (produced by Jinan Ltd. Pharmaceutical) and reference preparation of lansoprazole tablets (produced by Shantou Tabin Pharmaceutical), one week interval between the agent, and the dose are30mg. By pharmacokinetic parameters calculating, Test preparation t1/22.166±1.217h, Cmaxl.644±0.677ng/ml, Tmax2.688±0.640h, AUC0-15h5.977±3.692μg-h/ml. And reference preparation t1/21.771±0.763h, Cmax1.490±0.569μg/ml, Tmax3.292±0.779h, AUC0-15h5.609±3.015μg·h/ml. Using the area estimation method, the test preparation was105.46%±33.03%compared with the reference preparation, and it met the requirements of biological utilization.The test and reference preparation of In (AUC0-15h), In (AUC0-∞) were statistical analyzed by variance analysis, and the results showed that there were no significant differences between the two agents, the confidence intervals were89.7%～112.7%,91.3%～115.1%,80%～125%, the two agents have bioequivalent in extent of absorption. The test and reference preparations of In (Cmax) by variance analysis, there was no significant difference between the two agents, the confidence interval was in the70%～143%range. The result showed that the two preparations were bioequivalent in peak concentration.