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

Primary Purpose

Renal Insufficiency, Chronic

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Eritromax

Eprex

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Erythropoeitin, Chronic kidney disease, Anaemia

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Acute disease in the period of 07 days prior to inclusion;
Chronic administration of medication to determine, such as high blood pressure;
Hormone therapy in the period of 02 months prior to inclusion;
Administration of any drug in the 02 weeks prior to inclusion;
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.

Sites / Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test ERITROMAX

EPREX

Arm Description

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

Janssen-Cilag Recombinant Human Erythropoietin (EPREX)

Outcomes

Primary Outcome Measures

Pharmacokinetic - rHuEPO concentration.

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

Pharmacodynamics - Absolute Reticulocyte Count.

Will evaluated through the absolute reticulocyte count at total blood.

Secondary Outcome Measures

Full Information

NCT ID

NCT03572647

First Posted

November 3, 2011

Last Updated

November 1, 2022

Sponsor

Azidus Brasil

Collaborators

Blau Farmaceutica S.A.

1. Study Identification

Unique Protocol Identification Number

NCT03572647

Brief Title

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

Official Title

Randomized Clinical Study for Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax, Marketed by the Blausiegel Laboratory, Compared to Drug Eprex, Produced by Janssen-Cilag Laboratory, in Healthy Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azidus Brasil

Collaborators

Blau Farmaceutica S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This a prospective randomized and crossover study for evaluation of pharmacokinetics and pharmacodynamics of two epoetins formulations. The subjects will receive in each confinement period 4000 IU one of the investigational product subcutaneously, according to randomisation, separated by a washout period of 4 weeks. The evaluation of the profile between products included serum dosage of medications and reticulocyte count in peripheral blood. Safety evaluation data will include report od all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product study).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic

Keywords

Erythropoeitin, Chronic kidney disease, Anaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test ERITROMAX

Arm Type

Experimental

Arm Description

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

Arm Title

EPREX

Arm Type

Active Comparator

Arm Description

Janssen-Cilag Recombinant Human Erythropoietin (EPREX)

Intervention Type

Drug

Intervention Name(s)

Eritromax

Other Intervention Name(s)

epoetin alfa

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Eprex

Other Intervention Name(s)

epoetin alfa

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetic - rHuEPO concentration.

Description

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

Time Frame

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.

Title

Pharmacodynamics - Absolute Reticulocyte Count.

Description

Will evaluated through the absolute reticulocyte count at total blood.

Time Frame

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; Acute disease in the period of 07 days prior to inclusion; Chronic administration of medication to determine, such as high blood pressure; Hormone therapy in the period of 02 months prior to inclusion; Administration of any drug in the 02 weeks prior to inclusion; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Frederico, PI

Organizational Affiliation

LAL Clinica Pesquisa e Desenvolvimento Ltda

Official's Role

Principal Investigator

Facility Information:

Facility Name

LAL Clínica Pesquisa e Desenvolvimento Ltda.

City

Valinhos

State/Province

São Paulo

ZIP/Postal Code

13270000

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.

Learn more about this trial

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

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