07.Feb.2012

OCT-Clinical trials in CEE finalize documents for a new bioequivalence study

The study will be performed in a phase I unit in Russia. The investigational product will be used for the treatment of benign prostatic hyperplasia.

OCT have initiated activities in relation to an single dose two-way crossover clinical study of the study formulation compared to capsules in healthy male subjects. The study will be performed in a phase I unit in Russia.

The investigational product will be used for the treatment of benign prostatic hyperplasia.

Usually, if this disease is not treated in a right way it can cause risks of urine flow obturation, and consequently may lead to the need for surgery. Benign Hypertrophic Prostate (BHP) is considered a benign neoplasm, it does not metastasize. However, the tumour can grow in size and, in this way, bring problems with urination processes compressing the male urethra.

BHP is one of the most widely spread indication in urology. According to statistics, every second man after 50 suffers from BHP. It is considered that this medical condition is progressing in about 85% of men.

Among clinical complications in relation to BHP are such as erythrocyturia (in other words, blood in urine). When urine pressure in bladder increases veins may be harmed, which leads to bleeding. Another medical complication is bladder calculi, which appear as a result of urine congestion in the bladder.

It is advisable for men after 50 to have urologist examination and corresponding procedures done every half a year in order to diagnose the disease, if any, in due time and take the appropriate measures.

OCT will be responsible for the major activities in the study including documents design, project management, clinical monitoring, interaction with the clinical facility and the analytical laboratory, data management, final report preparation.