Discussion And Conclusions

This study was a single-center, open-label, randomized, single-dose study with two-way crossover design to compare the bioavailability of metformin between two products, in 24 healthy, adult, male volunteers.

The results of this bioequivalence study showed the equivalence of the two studied products in terms of the rate of absorption as indicated by Cmax and in terms of the extent of absorption as indicated by AUC0 _, t and AUC0 _, . The parametric 90% confidence intervals of the mean values for the test/reference ratio were in each case well within the bioequivalence acceptable boundaries of 80.00% to 125.00% for the pharmacokinetic parameters AUC0_,t and AUC0^ „ and for Cmax, to be within 75.00% to 133.00%.

ANOVA analysis on the log-transformed data, Cmax, AUC0 _, t, and AUC0 _, , and untransformed data for Cmax, AUC0 _, t, AUC0 _, , Ke, t(1/2)e, and imax showed that sequence effect, product, or period effect for all these parameters did not significantly influence the outcome of the study. The mean plasma curves of both products are almost superimposable, suggesting that not only Cmax and AUC but also the time course of plasma levels over the whole sampling period are identical.

Since plasma levels are a meaningful surrogate for pharmacodynamic action and AEs, this demonstrates that an equivalent therapeutic activity and tolerance is to be expected from Dialon tablet [Gulf Pharmaceutical Industries (Julphar), U.A.E.] generic product when compared with Glucophage tablet (Merck, France), the reference product.

Was this article helpful?

0 0

Post a comment