This was an open-label, randomized, two-period, crossover study in healthy volunteers. The objective of this study was to evaluate comparative pharmacokinetics and bioequivalence of the investigational and reference products.
In recent years, highly active antiretroviral therapy (HAART) is being used increasingly often for immune system recovery and improvement of quality of life of HIV patients. The reference product belongs to a new-generation of protease inhibitors. Successful clinical studies and commercial distribution of the investigational drug will provide an opportunity to raise affordability of this kind of medicinal product for HAART.
Over 40 healthy volunteers were randomized into the trial during several enrollment periods in one of the phase-I units. The target enrollment rate was achieved within 21 days. Over 90% of patients were enrolled into the study during the first week.
According to the Sponsor’s request, the analytical lab was selected in Europe. OCT managed to organize its work rapidly and to obtain an export license for bio-samples, as well as to comply with all deadlines for logistical arrangements. The total duration of the project, starting from writing of essential documents (Protocol, IB and ICF) and up to the preparation of a final report, was just 8 months.
OCT’s experience in bioequivalence studies allowed to complete the project within tight deadlines, providing high patient enrollment rate and high quality of the study.