drugset / Trial / NCT03572647

Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax Compared to Eprex in Healthy Subjects.

NCT03572647

Phase 1 Completed 40 enrolled Azidus Brasil Blau Farmaceutica S.A. · collab
RandomizedCrossoverOpen-labelTreatment

Summary

The epoetin is a glycoprotein and endogenous hormone, which is primarily synthesized by specific epithelial cells lining the kidney peritubular capillaries, and regulates continuous formation of red blood cells. This is a pharmacokinetics and pharmacodynamics study, in which each subject will receive the investigational product in different periods, as randomisation (Teste or Comparator). The evaluation of the profile included serum dosage of medications and reticulocyte count in peripheral blood.

Timeline

Start
2012-11
Primary completion
2012-11
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator epoetin alfa Protein / enzyme biologic 4000 iu Subcutaneous