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What is Bioequivalence Study of Feniramidol 400 mg about?

This document outlines a clinical study protocol for an open-label, randomised, single oral dose, four-period, replicated, cross-over trial to assess the bioequivalence of Feniramidol HCl 400 mg Film Tablet compared to Cabral 400 mg Film Tablet in healthy male subjects under fed conditions. The study, sponsored by Pharmactive İlaç San.ve Tic. A.Ş., aims to evaluate pharmacokinetic variables and safety endpoints with a planned duration of approximately 6 weeks. The study will adhere to Good Clinical Practice

Author

Neneng Aini Karuniawan

Language

EN