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

NCT03572647 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency, Chronic

Interventions

DRUG

Eritromax

The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.

DRUG

Eprex

The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.

Sponsors & Collaborators

  • Blau Farmaceutica S.A.

    collaborator INDUSTRY

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Alexandre Frederico, PI · LAL Clinica Pesquisa e Desenvolvimento Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-11-30
Completion
2013-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572647 on ClinicalTrials.gov