Bioequivalence Study of Easyrect 100 Mg Tablets Versus Spedra® 100 mg Tablets after a Single Oral Dose Administration of Each to Healthy Volunteers Male Adults under Fasting Conditions

Authors: Eliwa HA¹* and Eldin AAA²

DOI: 10.23880/beba-16000134

Volume 2, Issue 3

Abstract

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

View PDF