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

Information source: Biocad
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Darbepoetin alfa (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Biocad

Official(s) and/or principal investigator(s):
Ivan Sardaryan, PhD, Principal Investigator, Affiliation: City Mariin Hospital

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

AUC

Cmax

AUEC

AC-Emax

Secondary outcome:

T1/2

Tmax

Cl

Hemoglobin

RBC

Hematocrit

AE and SAE Incidence

AE Grade 3-4 Incidence

Local reactions

Study Withdrawal Rate Due to AE

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Locations and Contacts

City Mariin Hospital, St. Petersburg 194104, Russian Federation
Additional Information

Related info

Starting date: March 2013
Last updated: July 22, 2015

Page last updated: August 20, 2015

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