12.Apr.2017

OCT to start a bioequivalence study of drug products for multiple myeloma treatment

This is an open-label, single-center, randomized, crossover, comparative pharmacokinetic and bioequivalence study of drug products in healthy volunteers under fasting conditions.

It is planned to enroll male subjects aged 18-45. A total number of screened volunteers will not exceed 40. The study participants are expected to be randomized in a 3-month period. The total duration of the study will be 12 months. The study design consists of two dosing sequences and includes a single dose administration of each investigational product.

Multiple myeloma (MM) accounts for 20% of all hematological malignancies. The incidence of MM is generally higher among men than in women. The prognosis for MM is unfavorable with age-standardized European 5-year survival rate of 29% in men and 33% in women. The standard treatment of MM is systemic chemotherapy and supportive treatment. The investigational drug is a generic equivalent of the reference drug, which combines high efficacy and favorable safety profile.

In this study, OCT provides full range of services (regulatory support not included). OCT team of the industry’s best professionals has successfully completed more than 200 I-IV phase clinical trials, as well as bioequivalence studies. A large part of our portfolio comprises turnkey projects in which we take care of all crucial steps in the conduct of clinical trials. Our experts also provide consulting and regulatory support for projects in Russia, Europe and USA.