U.S., April 10 -- ClinicalTrials.gov registry received information related to the study (NCT06919861) titled 'The Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine Produced by Nanogen Pharmaceutical Joint Stock Company' on March 26.
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(R) of Janssen Cilag Ltd on healthy male volunteers.
The biosimilarity of erythropoietin (EPO) between Nanokine (test) and Eprex(R) (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 alter...