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Pharmacokinetics and Pharmacodynamics Study of BCD-066 Compared to Aranesp® in Healthy Volunteers

NCT02506881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-06-14

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Darbepoetin alfa

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Ivan Sardaryan, PhD · City Mariin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506881 on ClinicalTrials.gov