Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine Produced by Nanogen Pharmaceutical Joint Stock Company
brief 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.
detailed description
Erythropoietin (EPO) is a glycoprotein hormone essential for red blood cell (RBC) formation, primarily produced in the kidneys. Recombinant human erythropoietin (rHuEPO) or erythropoiesis-stimulating agents (ESAs) are used to treat anemia in chronic renal failure, chemotherapy-induced anemia, and to reduce transfusion needs in surgery.
Nanokine, currently considered as a follow-on biological product of Eprex® developed by Nanogen Biopharmaceutical JSC, is produced in CHO cells. This study evaluates the bioequivalence of Nanokine and Eprex® in healthy volunteers, comparing pharmacokinetics (PK), pharmacodynamics (PD), and safety.
A randomized, double-blind, single-dose, two-sequence crossover trial was conducted in 44 healthy male volunteers (19-45 years, BMI 18.0-27.0 kg/m²). Participants received a 4,000 IU subcutaneous injection of either Eprex® or Nanokine, followed by the alternate after a 28-day washout. Blood samples for PK analysis were taken at multiple time points up to 144 hours postdose, while PD markers (reticulocyte count, hematocrit, hemoglobin, RBC count) were measured up to 312 hours postdose.
This study is conducted at the Center for Clinical Pharmacology-Hanoi Medical University, following the Vietnam guideline of Biomedical research, ethical, and regulatory guidelines.
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