Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers
brief summary
Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population
detailed description
An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover design will be used to study the pharmacokinetics and pharmacodynamics of two different rHuEpo products when administered subcutaneously in healthy subjects.
PK parameters to evaluate shall be AUCt and AUCt to infinity, and Cmax PD parameter shall be erithrocye and reticulocyte counts and hematocrite. Bioequivalence shall be evaluated according to 80-125 T/R rate for 90 % Cmax and AUC for pk and PD parameters.
official title
Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.