In this study, the new formulation of an immediate release tablet will be investigated. For this purposes over 20 healthy volunteers were expected to be enrolled. It took OCT only one day to complete the enrollment of 22 man and women aged between 18 and 45 years old. Enrollment took place at one selected investigational site. The study treatment was started right after randomization.
The reference drug has been used for many years as a symptomatic treatment of inner ear diseases and vestibular vertigo. Its post-marketing experience has demonstrated its safety and good tolerability with a favorable side-effect profile.
The new formulation presented by the study sponsor is expected to be more convenient for patients.
This study is conducted in accordance with applicable Russian regulatory requirements to support the marketing authorization.
In this project OCT provides regulatory support and study plan development, project management, control of site-related issues, including site monitoring, logistics and reporting. Data MATRIX is responsible for data management activities (CRFs and biostatistics).
Bioequivalence studies are special type of clinical studies with particular designs, methods of their conduct and result analyses. In such studies small groups of healthy volunteers receive both treatments consecutively. The two treatments are considered therapeutically equivalent if they are pharmaceutically equivalents and if they have the same bioavailability and demonstrate comparable efficacy and safety profile after administration in the same molar dose.
With solid experience in bioequivalence studies in Russia and Eastern Europe, OCT may guarantee the delivery of high quality results in every single project.