PK and PD Crossover Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant Epoetin and Eprex, in Healthy Subjects.

Summary

The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration of 100 IU/kg in healthy subjects.

Timeline

Start

2013-02-28

Primary completion

2013-10-31

Completion

2013-10-31

Drugs

Indications

No indication recorded.