OCT will conduct a randomised, single-dose, 2-way crossover, open-label, bioavailability study in healthy volunteers in Russia. The study is initiated and sponsored by a large European-based pharmaceutical company which is a long-standing partner of OCT.
The primary objective of this study is to determine and compare the rate and extent of absorption of an investigational product in comparison with a reference drug. The trial is conducted in order to obtain a marketing authorization for the investigational drug.
One investigational site is expected to take part in this study with a total of 26 randomized healthy volunteers. In this project OCT provides a full service support. At the moment, the company makes all necessary arrangements for the pre-clinical study, which will be followed by the application to the Ministry of Healthcare of Russia for approval of the bioequivalence study.
The common cold is an upper respiratory tract infection caused by a variety of viruses that manifest their presence with several symptoms. The use of a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a decongestant in the indication of common cold and flu is widely accepted. Viral upper respiratory tract infections produce multiple symptoms such as headache, sore throat, body aches and pains, runny nose, blocked nose, sinus pain, and fever. To provide fast, effective, temporary relief of the major symptoms associated with cold and flu and without causing drowsiness, the Sponsor updated the formula of the earlier registered drug which already proved its effectiveness.
OCT has a wide experience of clinical trials in respiratory diseases. During the last several years our company completed 6 projects in this therapeutic area, including pre-clinical trials. With its in-depth expertise OCT managed to become the leading local CRO in Central and Eastern Europe and set the high level of quality of clinical trials in Russia.