Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and
safety of BCD-066 (darbepoetin alfa manufactured by CJSC BIOCAD, Russia) and Aranesp® (Amgen
Europe B.V., Netherlands) in healthy volunteers. The purpose of the study is to demonstrate
the equivalence of pharmacokinetics, pharmacodynamics and safety parameters after single
subcutaneous or intravenous injection. Each drug will be administered to each volunteer at a
dose of 1 µg per kilogram as a single subcutaneous or intravenous injection with an interval
of at least 25 days.