Comparative Bioavailability of Sildenafil 50-mg Film-Coated Tablets and 50-mg Orally Disintegrating Films in Healthy Mexican Subjects: Results From a Randomized, Open-Label, Crossover Study.

An orally disintegrating film formulation of sildenafil 50 mg (CL Pharm Co, Ltd) was used in this study and compared to the market-available product film coated tablets (Viagra , Pfizer, Mexico). The objective was to compare the pharmacokinetic properties of these products after a single-dose administration to 47 healthy male volunteers (aged 19-48 years) in a randomized, open-label, 2-way crossover study. Each subject received a single oral dose of 50 mg of sildenafil test or reference product administered under fasting conditions at each of the 2 study periods according to a crossover design.