臨床および実験薬理学ジャーナル

概要

Pharmacological Study of Sildenafil on Healthy Volunteers

Eliwa HA, Eldin AA and Salah MM

The present study is a comparative single-dose, open-label, randomized, three-treatment, six-sequence, threeperiod, crossover, in vivo study to determine the bioequivalence of two test products: Test 1; Sildenamax (Sildenafil 100 mg), Test 2; Satenafil (Sildenafil 100 mg) manufactured by Organo for Pharmaceutical and Chemical Industries, versus VIAGRA® (Sildenafil 100 mg) manufactured by Pfizer Egypt, USA and its Subsidiary in UK after a single oral dose administration given to healthy adult volunteers under fasting conditions. The subjects who conform to the study entry criteria were dosed according to a randomization schedule. Furthermore, the study was designed and completed according to the good clinical and laboratory practices.