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PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant

Healthy Clinical Trial

Official title:
Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.

Clinical Trial Summary

The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01685359
Study type Interventional
Source Azidus Brasil
Contact
Status Completed
Phase Phase 1
Start date February 28, 2013
Completion date October 31, 2013
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