Recombinant Filgrastim (BK0023) Pharmacodynamics and Pharmacokinetics after Single and Multiple Escalating Doses in an Equivalence Study in Healthy Men

Andrea F. D. Di Stefano,Gaia Spinetti,Antonio Rusca,Milko M. Radicioni,Luca Loprete, Domenica M. G. Lamparelli, Jutta Michael Hepp, Davide Crobu,Rodolfo Schrepfer,Giancarlo Tonon

Clinical drug investigation（2015）

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摘要

The new filgrastim formulation, BK0023, whose synthesis method is patented, was tested in a phase I clinical study that was aimed at investigating the pharmacodynamic and pharmacokinetic equivalence and the safety of BK0023 in healthy male subjects.

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关键词

Absolute Neutrophil Count,Filgrastim,Reference Product,Pharmacodynamic Parameter,Neupogen

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