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Arzneimittelforschung 2008; 58(5): 215-219
DOI: 10.1055/s-0031-1296497
Therapeutics for States of Deficiency
Editio Cantor Verlag Aulendorf (Germany)

Evaluation of the Pharmacokinetics of Two Recombinant Human Erythropoietin Preparations: Epoetin Zeta and Epoetin Alfa

1st Communication: A monocentric, open, randomized, single dose, two-period crossover trial in healthy volunteers
Valentin Kirkov
1   University Hospital “Queen Giovanna”, Sofia, Bulgaria
,
Velislava Dimitrova
2   University Hospital “Sveti Ivan Rilski”, Sofia, Bulgaria
,
Marianne Siebert-Weigel
3   STADA R&D GmbH, Bad Vilbel, Germany
,
Michael Wolf-Pflugmann
3   STADA R&D GmbH, Bad Vilbel, Germany
,
Rossen Koytchev
4   Cooperative Clinical Drug Research and Development (CCDRD) AG, Neuenhagen, Germany
,
Wolfram Richter
4   Cooperative Clinical Drug Research and Development (CCDRD) AG, Neuenhagen, Germany
,
Angelika Bronn
4   Cooperative Clinical Drug Research and Development (CCDRD) AG, Neuenhagen, Germany
,
Sacha Arsova
4   Cooperative Clinical Drug Research and Development (CCDRD) AG, Neuenhagen, Germany
,
Arno Kromminga
5   IPM GmbH, Hamburg, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
15 December 2011 (online)

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Abstract

The pharmacokinetic properties of a new recombinant erythropoietin preparation (epoetin zeta, CAS 604802-70-2) compared to a reference product (epoetin alfa, CAS 113427-24-0) were analyzed after a single intravenous bolus injection of 10,000 IU in a two-period crossover design in 24 healthy volunteers. Peripheral venous blood samples were obtained pre-dose, and 0:05, 0:20, 0:40, 1:00, 1:20, 1:40, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 36:00, 48:00, and 72:00 hours post dosing. Samples of 24 volunteers were analyzed by means of a specific immunoassay (ELISA).

Three volunteers were excluded from statistical analysis due to a paravasal injection in one of both study periods with resulting low plasma levels of epoetin.

Comparison of both preparations showed nearly identical pharmacokinetic properties after intravenous administration. The usual bioequivalence limits were fulfilled for all relevant pharmacokinetic parameters.

Key words

CAS 113427-24-0 - CAS 604802-70-2 - Epoetin alfa, bioequivalence, biosimilar, pharmacokinetics - Epoetin zeta, bioequivalence, biosimilar, pharmacokinetics
 

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