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Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine Produced by Nanogen Pharmaceutical Joint Stock Company
Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
Summary
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, double-blind, two-sequence, crossover 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) markers (reticulocyte count, hematocrit, hemoglobin, and RBC 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.
Official title: A Randomized, Double-blind, Two-group Crossover Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine (Nanogen) With Eprex® (Janssen-Cilag Ltd) in Healthy Male Volunteers
Key Details
Gender
MALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-06
Completion Date
2025-12
Last Updated
2025-05-23
Healthy Volunteers
Yes
Conditions
Interventions
Erythropoietin alfa
Experimental drug: Nanokine 4000 IU, prefilled syringe, subcutaneous injection Manufactured: Nanogen Biopharmaceutical JSC. Arm 1 (22 volunteers): Nanokineinjection 4000 IU will be administered subcutaneously on Day 1, and after a 28-day washout period, Eprex® injection 4000 IU will be administered subcutaneously on Day 29.
Erythropoietin alfa
Comparator drug: Eprex® 4000 IU, prefilled syringe, subcutaneous injection Manufactured: Janssen-Cilag Ltd Arm 2 (22 volunteers): Eprex® injection 4000 IU will be administered subcutaneously on Day 1, and after a 28-day washout period, Eprex injection 4000 IU will be administered subcutaneously on Day 29. Total: 44 participants will be recruited in the trial.