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.
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Inclusion Criteria:
- Signed written informed consent
- Male gender
- Age 18 - 45 years inclusively
- Body mass index (BMI) 19 - 29 kg/m2 inclusively
- Hemoglobin level 120-160 g/l (12 - 16 g/dL) inclusively during 14 days prior to first
study drugs administration
- White blood cells count ≥3,0×109/L, Platelet count ≥140×109/L during 14 days prior
to first study drugs administration
- Subjects must be in good health as determined by a medical history, medical
examination, electrocardiogram, serum biochemistry, haematology, serology and
urinalysis
- Absence of history of systematic alcohol and drug abuse
- Ability of the volunteer, in investigator's opinion, to follow the study protocol
procedures and requirements
- Willingness of volunteers and their sexual partners of childbearing potential to use
reliable contraception methods starting from 2 weeks before inclusion into the study
and until 4 weeks after receiving the last dose of the investigational products. This
criterion is not applicable to patients who underwent surgical sterilization.
Reliable contraceptive measures include one barrier method in combination with one of
the following methods: spermicides, intrauterine device or oral contraceptives used
by participant's partner
- Consent to avoid alcohol intake within 24 hours before and 48 hours after each
administration of the test or reference drugs
Exclusion Criteria:
- Clinically significant abnormalities on ECG or in laboratory tests, which could
interfere with the objective of the study or the safety of the volunteer.
- Clinically significant illness within 4 weeks prior to the screening visit
- Subjects with past or present history of liver disease, angina, renal disease,
hypertension, epilepsy, cardiovascular, cerebrovascular, peripheral vascular disease
or thrombocytosis
- History of any oncological disease
- Prior exposure to any erythropoietins, darbepoetin
- Prior exposure to IV iron supplementation (within 2 years before randomisation)
- Subjects who have used any medication, including over-the-counter drugs, herbal
medications, and nutritional supplements within 14 days prior to IDs administration
with the exception of paracetamol (acetaminophen) up to 3g per day or ibuprofen up to
1g per day
- Subjects who smoke more than 10 cigarettes per day
- Subjects who have donated more than 450 ml of blood within the 1 month prior to ID
injection
- Epileptic seizures within the 6 months prior to ID injection
- Major surgery within 1 month prior to the enrollment into the study
- Inability to install intravenous catheter (e. g., due to skin disease)
- Subjects who have received any experimental drug within 3 months preceding the 1st ID
administration
- Subjects who have a clinically significant history of drug hypersensitivity or
allergic disease
- Possibility that the subject will not cooperate with the requirements of the protocol
as set out in the volunteer information
- Subjects who consume excessive amounts of caffeine (more than 5 cups of coffee per
day)
- Participation in any other clinical study or any preceding participation in other
studies within 3 months prior to the 1st ID administration