Approval obtained for a bioequivalence study sponsored by an international pharmaceutical company

This is an open-label, randomized, single dose, two-way, cross-over, bioequivalence study aiming to compare pharmacokinetics of the investigational and reference substances administered in the same doses.

This study will be carried out in healthy volunteers with more than 20 men and women aged from 18 to 45 to be enrolled. For this purpose, 30 volunteers are expected to be screened in one investigational site; the planned duration of the study is two months.

The reference drug is approved in 118 countries and indicated for the 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 test product is a new formulation of the marketed product which is expected to be more convenient for patients having difficulty in swallowing tablets, nausea, etc.

This study will be conducted in accordance with applicable Russian regulatory requirements in order to support the application for marketing authorization.

In this project OCT will be responsible for review of study documents prepared by the Sponsor, preparation of patient informed consent forms, monitoring plan, communication with the medical institution and ethics committee, full project support, data management, logistics, final report preparation and submission to regulatory authorities.

Learn more about OCT experience across a variety of study phases and indications.