None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Intravenous administration of Test product(PDA10) or Reference product(Eprex®) according to randomization code. The dose to be administered was calculated from th
Sponsors
PanGen Biotech
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male adults aged 20 ~ 45 at screening. 2. Body weight = 60 kg and within ± 20% of the ideal body weight. 3. Wiling to provide own written informed consent to trial participation based upon full understanding of what is explained in detail about the study and agree to comply with the study instructions.
Exclusion criteria
Exclusion criteria: 1. Clinically significant hepatic, renal, neurological, respiratory, hematologic / oncologic, cardiovascular, psychiatric or endocrine disorder, either current or prior. 2. Risk of severe venous thrombosis including prior history of myocardial infarction, heart attack, unstable angina or venous thrombocytic thrombus. 3. History of hypersensitivity or any clinically significant hypersensitivity reaction to epoetin-containing products or other drugs (aspirin, antibiotics, etc.). 4. Test positive for Hepatitis B Virus Surface Antigen, Hepatitis C Virus Antibody or Human Immunodeficiency Virus Antibody. 5. Known sensitivity to mammalian cell derived products. 6. Systolic blood pressure = 90 mmHg or diastolic blood pressure = 50 mmHg OR systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg, as measured in a sitting position after resting for at least 3 minutes. 7. History of drug abuse. 8. Having taken any prescription drug, folk medicine or herbal supplement within 2 weeks prior to first dose, or any Over The Counter drug or vitamin product within 1 week prior to first dose. 9. Having participated in any other clinical research within 1 month prior to first dose. 10. Whole blood donation within 2 months prior to first dose or apheresis donation within 1 month prior to first dose, OR blood transfusion within 1 month prior to first dose. 11. Smoking more than 10 cigarettes per day on average in the last 3 months. 12. Persistently drinking alcohol (more than 21 units/week, 1 unit = 10 g of pure alcohol) or unable to abstain from alcohol and smoking. 13. Ineligible for study participation due to other reasons including clinical laboratory findings, according to the investigator’s judgment. 14. Hemoglobin, hematocrit and ferritin levels above the upper limit of normal range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from intravenous administration to 48 hours;Maximum plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the effect-time curve from intravenous administration to 28 days;Maximum reticulocyte count | — |
Countries
Korea, Republic of
Contacts
Public ContactDOO-YEOUN CHO
Ajou University Hospital
Outcome results
None listed