Exemestane PH&T proved bioequivalent to Aromasin^Ò (Pfizer)

December 2009 PH&T has developed Exemestane, the generic formulation of Aromasin® 25mg (Pfizer). 
Recently PH&T conducted a bioequivalence study to characterize the pharmacokinetic profile of its formulation (Exemestane PH&T 25mg sugar coated tablets) relative to that of reference formulation (Aromasin® 25mg sugar coated tablets).

The study was open label, balanced, randomized, two-sequence, two treatment, two-period, single oral dose, crossover, performed in 56 normal, healthy postmenopausal human female subjects under fed conditions. The safety of the subjects was also monitored.
According to the EMEA last “Guideline on the Investigation of Bioequivalence”, the primary pharmacokinetic parameters used to estimate concentration vs. time profiles of exemestane were Cmax and AUC0-t and the bioequivalence of the test product with that of the reference product under fed conditions was concluded if the 90% confidence interval falls within the acceptance range of 80.00–125.00% for ln-transformed pharmacokinetic parameters Cmax and AUC0-t for exemestane.
On the basis of statistical  analysis, the ln-transformed results of Cmax and AUC0-t completely fall into 90% confidence interval, showing the clear bioequivalence between Exemestane PH&T 25mg and Aromasin 25mg.