OCT has obtained the study approval for the initiation of the bioequivalence study with a combination product. This single dose two-way crossover clinical study of the investigational medicinal product compared to capsules in healthy male subjects will be performed at a phase I clinical unit in Moscow, Russia. The medicinal product is aimed at treating benign prostatic hyperplasia in men.
Prior to inclusion of the subjects in the study, the pharmacogenetics analysis tests will be performed in order to exclude subjects with slow metabolizers CYP2D6. The method validation and analyses performance for such testing is widespread in not that many laboratories, however the ones, which perform the analyses, have been identified and will participate in the clinical study this way.
The clinical institution, at which the clinical part of the study will be conducted, is one of the leading institutions of such profile in the Russian Federation. In order to be able to hospitalize healthy subjects, a clinic must possess a special kind of license, which allows for such hospitalisation (mainly, for phase I studies in healthy volunteers as well as bioequivalence trials). The phase I unit should have all the necessary equipment, facilities (for instance, a very crucial one is the emergency care unit within the hospital), a kitchen, laboratory devices and equipment for blood sampling, safety analysis, screening procedures, etc. It is valuable if a phase I unit has enough beds to place standard as well as non-usual design studies. In most cases, such hospitals have from 12 up to 40-50 beds, which allows for allocating parallel bioequivalence studies, too (for instance, two groups of 18 subjects, etc.)
The clinical site and the bio-analytical laboratory selected by Sponsor together with OCT for the study have been approved. The project is one of several ones discussed with Sponsor, who strategically plans to prolong collaboration and cooperation with OCT for its future projects, which are on the way already.