Amiloride bioequivalence studies

Executive Summary

FDA guidelines state that studies should consist of a two treatment single dose crossover design comparing the test product with the reference product, MS&D's Midamor, in 24 males. "Analytical data for 24 subjects should be evaluated by ANOVA to determine if there are statistically significant differences (p. < 0.05) between the dosing groups," the guidelines state. "Evaluation of bioequivalence should be based upon comparison of the plasma AUC, Cmax, and Tmax values between the two drug products".