Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and
tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif®
(Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to
demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability
parameters after single subcutaneous injection. Each dtug will be administered to each
volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least
14 days.