ISSN: 2578-4803
Authors: Eliwa HA1* and Eldin AAA2
This study was a comparative single-dose, open-label, randomized, two-treatment, two-sequence, four-period, fullreplicate crossover, in-vivo study to determine the bioequivalence of Easyrect 100 mg Tablets (Avanafil100 mg) manufactured by Egyptian Group for Pharmaceutical Industries for Zeta Pharm for Pharmaceutical Industries versus Spedra® 100 mg Tablets(Avanafil100 mg) manufactured by Menarini International Operations Luxembourg S.A. after a single 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. The study was designed and completed according to the good clinical and laboratory practices.
Keywords: Bioequivalence parameters (Cmax, AUC0-t, and AUC0-∞); Healthy volunteers; Avanafil ; MRC
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