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Pharmacokinetic and Pharmacodynamic Comparison of Two "Pegylated" Interferon Alpha-2 Formulations in Healthy Male Volunteers: a Randomized, Crossover, Double-blind Study by Idrian García-García; Carlos A González-Delgado; Carmen M Valenzuela-Silva; Alina Díaz-Machado; Marisol Cruz-Díaz; Hugo Nodarse-Cuní; Orlando Pérez-Pérez; Cimara H Bermúdez-Badell; Joel Ferrero-Bibilonia; Rolando Páez-Meireles; Iraldo Bello-Rivero; Fidel R Castro-Odio; Pedro A López-Saura; for the FarmaPEG Study Group is a Medicine article available to read on EtoBox.

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## Background Interferon (IFN) alpha conjugation to polyethylene glycol (PEG) results in a better pharmacokinetic profile and efficacy. The aim of this study was to compare the pharmacokinetic, pharmacodynamic and safety properties of a new, locally developed, 40-kDa PEG-IFN alpha-2b preparation with a reference, commercially available PEG-IFN alpha-2a in healthy male volunteers. ## Methods A randomized, crossover, double-blind study with a 3-weeks washout period, was done. A single 180 micrograms PEG-IFN alpha-2 dose was administered subcutaneously in both groups. Sixteen apparently healthy male subjects were included. Serum PEG-IFN concentration was measured during 336 hours by an enzyme immunoassay (EIA). Other clinical and laboratory variables were used as pharmacodynamic and safety criteria. ## Results The pharmacokinetic comparison by EIA yielded a high similitude between the formulations. In spite of a high subject variability, the parameters' mean were very close (in all cases p > 0.05): AUC: 53623 vs. 44311 pg.h/mL; Cmax: 333 vs. 271 pg/mL; Tmax: 54 vs. 55 h; half-life (t~1/2~): 72.4 vs. 64.8 h; terminal elimination rate (lambda): 0.011 vs. 0.014 h^-1^; mean residence time

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Author

Idrian García-García; Carlos A González-Delgado; Carmen M Valenzuela-Silva; Alina Díaz-Machado; Marisol Cruz-Díaz; Hugo Nodarse-Cuní; Orlando Pérez-Pérez; Cimara H Bermúdez-Badell; Joel Ferrero-Bibilonia; Rolando Páez-Meireles; Iraldo Bello-Rivero; Fidel R Castro-Odio; Pedro A López-Saura; for the FarmaPEG Study Group

Publisher

BioMed Central; Springer (Biomed Central Ltd.); London: BioMed Central, 2001-2012.; Springer Science and Business Media LLC (ISSN 1471-2210)

Published

2010

Language

EN

Field

Medicine (Life Sciences)