At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International Multicenter Comparative Randomized Double-blind Crossover Study of Pharmacokinetics, Pharmacodynamics and Safety of BCD-066 and Aranesp® After Single Subcutaneous and Intravenous Injection in Healthy Volunteers.
In Brief
A Phase 1 clinical trial evaluating Darbepoetin alfa for Healthy. Completed, enrolled 74 participants across 1 site.
Detailed 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.