This was an open-label, randomized, single-center, single-dose, three-period, three-treatment crossover study to investigate comparative pharmacokinetics and bioequivalence of the two formulations of the investigational fixed-dose combination product compared to the two drugs each containing one of the two active ingredients in healthy male and female volunteers under fasting state.
The aim of the Sponsor which is a world-known international pharmaceutical company was to obtain marketing authorization of the investigational drug in the Russian Federation.
To achieve registration the objective of this study was to compare pharmacokinetics and establish bioequivalence of an investigational product with the two drugs already registered in the Russian Federation.
The population to be studied was a general population from the Russian Federation, represented by healthy males and females of 18-45 years. 42 healthy volunteers have been recruited for the study within 1,5 months.
The overall duration of the study at the medicinal site did not exceed 6 months, as planned by the Sponsor.
For the current study, OCT has been providing full support starting from medical writing of the essential study documents (study Protocol, Investigator’s Medical Product Dossier, Informed Consent Form and Case Report Form, study manuals and drug labels); full project management and clinical monitoring, regulatory support including all submissions to the Ministry of Healthcare of the Russian Federation and the Local Ethics Committee; logistics support; Data Management and Statistics.
Since this is a registration study, OCT was also responsible for the registration dossier preparation and submission.
OCT has a serious experience in conducting bioequivalence studies (10 studies since 2005), as well as phase I studies in healthy volunteers (6 studies since 2005) – our team has been working with a number of phase I units which guarantee high enrollment rates and adequate quality of activities within study conduct.
Since bioequivalence study usually require pharmacokinetics analysis, OCT has a number of preferred bioanalytical laboratories both in Russia and other countries of our operations, which provides the opportunity to choose the one that would meet study’s and Sponsor’s requirements. Within the current study, OCT team has been working with a central laboratory in Moscow. Sometimes sponsor may have a need to use the analytical data derived from the clinical trial to register the investigational product in Europe. In such cases, one of the preferred and audited by OCT European central laboratories are contracted for the study.