20.Jun.2013

OCT has completed bioequivalence trial of fixed combination drug

OCT is happy to announce the completion of a bioequivalence study of a fixed combination drug in healthy male subjects.

OCT is happy to announce the completion of a bioequivalence study of a fixed combination drug in healthy male subjects, sponsored by a leading international pharmaceutical company. The final study report is currently under preparation by OCT clinical specialists.

The primary objective of this open-label, randomized, two-treatment, two-way crossover study was to determine the bioequivalence of the fixed combination investigational drug relative to a well-known treatment in healthy male subjects. Evaluation of the safety and tolerability of the investigational drug was the second, but not less important objective of the clinical trial.

The investigational drug is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, in order to reduce the risk of acute urinary retention and reduce the need for BPH-related surgery.

Benign prostatic hyperplasia (BPH), which is also known as benign prostatic hypertrophy, is a common degenerative disease among the older men all over the world. BPH can cause constriction of the urethra, leading to severe urinary problems.

Most elderly men have BPH problems: 50% of men in their 50s and 80% of men in their 80s show symptoms of BPH, which makes it the most common diagnosis made by urologists for men in age group of 45-74. According to the statistics, about 19 million people all over the world suffer from BPH symptoms, and only 3 million of those are diagnosed and treated. As for Russia, about 10-12% of all diseases here are urologic ones.

BPH is not a life-threatening disease; however, it can seriously affect quality of life. Thus, treatment of BPH patients is an important aim of the modern medicine, which confirms the significance of the conducted trial.

OCT has exhaustive therapeutic expertise in urology, including early and late stages of drug development. Our team includes urologists who are based in all countries of OCT operation which include Russia, Ukraine, Belarus and countries in Eastern and Central Europe. We offer our sponsors high enrollment potential and solid expertise in managing urology programs.

Conducting clinical trials, including ones of this therapeutic area, requires thorough feasibility and experience of OCT MD professionals to meet the goals of the trials. Russia, Central and Eastern Europe provide good clinical research environment for urology studies. Recognizing the challenges in this type of clinical trials, OCT selects highly-experienced professional investigators who have access to sufficient number of patients from the target population. OCT investigator database contains several hundred investigators experienced in urology trials in Russia, Central and Eastern Europe.