The mean concentration-time profiles for the two brands of lansoprazole 30 mg capsules are shown in Figure C.2. All calculated pharmacokinetic parameter values were in good agreement with the previously reported values (4-13). The pharmacokinetic parameters for both formulations are shown in Table C.17. For bioequivalence, evaluation various statistical modules were applied to AUCo->■ t, AUCo->■ oo, and Cmax as per current FDA guidelines (24). Table C.18 shows the results of the statistical analysis for AUC0 _, t, AUC0 _, «, and Cmax. Due to lack of normality of the ln-transformed data, the final conclusions of this study were based on the analysis done on the non-transformed data.
According to the mean plasma levels of 26 subjects completing the study, the relative bioavailability was found to be 101.8%, 101.9%, and 110.4% on the basis of mean AUC0_ t, AUC0_ oo, and Cmax, respectively.
Was this article helpful?