Comparable pharmacokinetics and pharmacodynamics of two epoetin alfa formulations Eporon^® and Eprex^® following a single subcutaneous administration in healthy male volunteers.

ABSTRACT:

Purpose

This study aimed to assess and compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties following a single subcutaneous injection of epoetin alfa (Eporon^®) with those of the comparator (Eprex^®) in healthy male subjects.

Subjects and methods

A randomized, double-blind, two-sequence, crossover study was conducted. Subjects were randomly assigned to receive a single dose, that is, 4,000 IU, of the test or comparator epoetin alfa. After 4 weeks, all subjects received the alternative formulation. The primary PK parameters, maximum observed concentration (C_max) and area under the curve extrapolated to infinity (AUC_inf), were calculated with the serum erythropoietin (EPO) concentrations from blood samples collected for

SUBMITTER: Yoon S 

PROVIDER: S-EPMC5667778 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature