Pharmacological Study of Sildenafil on Healthy Volunteers
Abstract
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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