Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers.

摘要: Objective The objective of the study was demonstration bioequivalence two recombinant human granulocyte colony-stimulating factor (G-CSF) formulations after subcutaneous administration 5 microg/kg and 10 comparing their pharmacokinetic pharmacodynamic profiles in healthy subjects. Methods This a randomized, single dose, two-period cross-over, two-arm with 14 days wash-out period. In total 56 subjects were included, 28 each dosage cohort (5 microg/kg). Using 1 : randomization ratio, randomly assigned to one four possible treatment-sequence groups. A dose test formulation (XM02) reference product (Neupogen, F. Hoffmann - La Roche, Ltd.) injected. serum G-CSF concentrations measured by enzyme-linked immunosorbent assay (ELISA) during 48 hours injection. absolute Neutrophil Count (ANC) determined automated hematology analyzer Coulter STKSTM (Beckman Coulter, Inc.) up 96 primary (AUC0-48, AUC0- yen Cmax) (ANC AUC0-96, ANC ANCmax) variables considered bioequivalent if 90% confidence intervals (CI) range 80 125%. Results 50 completed study: 24 26 parameters mg/kg group for both very close other. Single doses well tolerated. most frequent AEs were: headache, erythrocyturia myalgia. incidence equally distributed across treatment Conclusion results demonstrated body weight-dependent XM02, new filgrastim, Neupogen b.w. respect pharmacokinetic, safety profiles.