Leading mid-size Eastern European CRO approved to begin work on four bioequivalence studies sponsored by a pharmaceutical company in Europe.
ST. PETERSBURG, RUSSIA, December 3, 2020 /EINPresswire.com/ — OCT Clinical, a leading Eastern European CRO headquartered in Russia, today announced it has received approval to begin work on four bioequivalence studies sponsored by a European pharmaceutical company.
The first three are single-center, randomized, open-label, four-sequence, two-period crossover bioequivalence studies which will test three types of an investigational drug: 2.5mg, 10mg, and 20mg film-coated tablets of Rivaroxaban. The primary objective is to evaluate comparative bioequivalence in healthy volunteers. With enrollment targets of 42, 42 and 30 healthy male volunteers respectively, each study will consist of a month-long therapy with single-dose administration under fasting conditions.
The fourth, a randomized, open-label, four-sequence, two-period crossover bioequivalence study, will evaluate comparative pharmacokinetics and bioequivalence in healthy volunteers after administration under fasting conditions. The drug comes in 150mg capsules and will be tested with 56 healthy volunteers.
“We are excited to take on these projects and deliver to our maximum capacity. We are committed to meet the Sponsor’s goals within set timelines and budget,” said Irina Petrova, Director of Clinical Operations, OCT Clinical.
Within these projects, OCT Clinical is responsible for a wide scope of clinical trial services, including regulatory support, project management, monitoring, medical writing and logistics. For more information on OCT Clinical’s CRO services, visit www.OCT-ClinicalTrials.com/Services.
About OCT Clinical
OCT Clinical is the leading CRO in Russia, with operations in Central and Eastern Europe and the CIS region. With a team of over 200 professionals, the company provides a full range of high-quality clinical research services for phase I-IV and BE studies. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. OCT’s experienced team delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development. Since 2005, OCT Clinical Trials has worked on over 300 full-service and functional service projects in more than 20 therapeutic areas. Learn more at www.OCT-ClinicalTrials.com.
Source: EIN Presswire