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

NCT03572647 | Completed Phase 1

• 1 other identifier: EPOBLA0711I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Erythropoeitin; Chronic kidney disease; Anaemia

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic - rHuEPO concentration.

  Will evaluated through the plasma rHuEPO dosage before and after drug administration.

  Before administration (Time 0 hour) and after time 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 11 hours, 12 hours, 13 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours administration.

• Pharmacodynamics - Absolute Reticulocyte Count.

  Will evaluated through the absolute reticulocyte count at total blood.

  Before administration (Time 0 hour) and after Time 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours, 240 hours and 576 hours administration.

Study Arms (2)

Test ERITROMAX

EXPERIMENTAL

Blausiegel Industria e Comercio Ltda. Recombinant Human Erythropoietin (ERITROMAX)

Drug: Eritromax

EPREX

ACTIVE COMPARATOR

Janssen-Cilag Recombinant Human Erythropoietin (EPREX)

Drug: Eprex

Interventions

Eritromax DRUG

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

Also known as: epoetin alfa

Test ERITROMAX

Eprex DRUG

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

Also known as: epoetin alfa

EPREX

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
• Being male, aged between 20 and 55 years, clinically healthy;
• BMI between 18 and 25;
• Results of examination of hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
• Results of VCM, HBMC, platelets and leukocytes within the normal range:
• VCM = Between 82 to 98. Among the HBMC = 26 to 34. Among the platelets = 150,000 to 400,000 units per mL. Among the WBC = 3,500 to 10,500 units per mL and without cellular atypia.
• Serum ferritin = Male between 36 to 262 mcg / L and women between 24 to 155 mcg / L;
• Reticulocyte count in peripheral blood ≤ 3%;
• Serum erythropoietin less than 30 mIU / mL.

You may not qualify if:

• Participation in clinical trials in the 12 months preceding the survey;
• Presence of iron deficiency anemia;
• Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
• Chronic administration of medication to determine, such as high blood pressure;
• A history of autoimmune anemia or hereditary;
• research subjects with a history of chronic bleeding;
• research subjects with a history of acute bleeding in the last 30 days;
• History of sensitivity to biological products derived from mammals, albumin, or any component of the formulation;
• History of or current use at least 12 months of tobacco;
• Current or previous history (less than 12 months) of illicit drug use;
• previous therapy with erythropoietin;
• albumin below 3.5 g / dl or greater than 4.8 g / dL;
• Signs or clinical history of bone marrow aplasia;
• History of liver disease and clinical or laboratory;
• History of renal disease and clinical or laboratory.

Sponsors & Collaborators

• Azidus Brasil: lead
• Blau Farmaceutica S.A.: collaborator

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda.

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Alexandre Frederico, PI

  LAL Clinica Pesquisa e Desenvolvimento Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Alexandre Frederico

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: June 28, 2018
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

BR (1)