OСT announces the initiation of a new bioequivalence clinical study. The study is designed as a single-center, open-label, randomized, two-period, two-sequence crossover bioequivalence study in adult healthy male volunteers under fasting conditions. The study will be conducted at a single clinical site within the Russian Federation. Project implementation is planned under tight timelines.
The objective of the study is to compare the pharmacokinetic parameters and safety profile of the generic crizotinib product, 250 mg capsules, with the reference crizotinib product at the same dosage in adult healthy male volunteers under fasting conditions.
A total of 60 healthy male volunteers are planned to be randomized in the study. Eligible participants will be males aged 18 to 45 years with confirmed good health status based on medical examination results, non-smokers, with a body mass index ranging from 18.5 to 30 kg/m² and a body weight between 60 and 120 kg. Participants must be able to provide written informed consent and comply with the protocol requirements, including contraception measures and study-related restrictions throughout the study period.
Within the framework of this project, OСT is responsible for the development of the clinical study protocol, preparation of the informed consent form and investigator’s brochure, data management, study monitoring, biostatistical analysis, as well as partial preparation of the clinical study report.
