This is an open-label, randomized, replicative, four-period, two-sequence crossover study. The primary objective of the study is to evaluate the comparative pharmacokinetics and bioequivalence of the drug taken under fasting conditions.
During the two weeks since the opening of the investigational center, all of the volunteers have been enrolled. At the moment, all of the patients are randomized. Completion of participation is scheduled for June 2018.
The OCT team is responsible for site-management, monitoring, project management, logistics, quality assurance and producing a final clinical report.