26.Aug.2016

OCT is to start a bioequivalence study

This is an open-label, randomized, crossover study aiming to evaluate comparative pharmacokinetics and bioequivalence of test and reference products in HIV patients.

More than 40 healthy men and women aged from 18 to 45 will be randomized into the study. For that purpose, it is planned to screen 50 volunteers.

In recent years, highly active antiretroviral therapy (HAART) is being used increasingly often for immune system recovery and improvement of quality of life of HIV patients in Russian Federation. The investigational drug belongs to a new-generation of protease inhibitors. Successful clinical studies and commercial distribution of the investigational drug will provide an opportunity to raise affordability of this kind of medicinal product for HAART.

In this project, OCT is responsible for a full range of services related to clinical trial organization and performance, except for regulatory support. As part of the project, the OCT team handles such tasks as medical writing, interaction with central labs, data management, and final report preparation.