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OCT Clinical, a leading Eastern European CRO, 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.
OCT Clinical is now operating under Palleos Healthcare brand name.
“The merger will undoubtedly create significant synergies, not just doubling but squaring the expertise of both companies”, Philip Räth, Ph.D., managing director at Palleos, said in the release.
“OCT Clinical is proud to join forces with palleos healthcare, as it has an excellent reputation in the industry it serves. Now we can offer tailored solutions to our clients to meet their diverse clinical research needs and accelerate the time of bringing their products to market”, Dmitry Sharov, CEO at OCT Clinical.
