This clinical trial aims to compare the pharmacokinetic (PK), pharmacodynamic (PD) parameters, and safety between Nanokine of Nanogen Pharmaceutical Joint Stock Company and Eprex® of Janssen Cilag Ltd on healthy male volunteers. The biosimilarity of erythropoietin (EPO) between Nanokine (test) and Eprex® (comparator) was evaluated in a randomized, two-treatment, two-period, crossover, single-dose study. Subjects received a 4,000 IU subcutaneous dose of either formulation, followed by the alternate after a 28-day washout. Key pharmacokinetic (PK) parameters, Cmax and AUCinf, were assessed, with geometric mean ratios/GMR (90% CI) falling within the regulatory range (0.80-1.25). Pharmacodynamic (PD) marker (reticulocyte count) need to show comparable effects. Safety evaluation (adverse events and serious adverse events, other safety assessments such as vital signs, testing, and examination) supports their interchangeability in clinical use.
Age range
18 Years – 45 Years
Sex
MALE
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
AUC0-t
Timeframe: Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration)
Cmax
Timeframe: Pre-dose (30, 20, and 10 minutes before injection) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after injection).
AUC0-t of RET
Timeframe: Pre-dose (10 minutes before administration) and post-dose (12, 24, 48, 72, 96, 120, 144, 168, 216, and 312 hours after administration)
Cmax of RET
Timeframe: Pre-dose (10 minutes before administration) and post-dose (12, 24, 48, 72, 96, 120, 144, 168, 216, and 312 hours after administration)