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

Sponsor

Azidus Brasil (Industry)

Overall Status

Completed

CT.gov ID

NCT03572647

Collaborator

Blau Farmaceutica S.A. (Industry)

Enrollment

Location

Arms

5.9

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic	Drug: Eritromax Drug: Eprex	Phase 1

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test ERITROMAX Blausiegel Industria e Comercio Ltda. Recombinant Human Erythropoietin (ERITROMAX)	Drug: Eritromax The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation. Other Names: epoetin alfa
Active Comparator: EPREX Janssen-Cilag Recombinant Human Erythropoietin (EPREX)	Drug: Eprex The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation. Other Names: epoetin alfa

Arm

Intervention/Treatment

Experimental: Test ERITROMAX

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

Drug: Eritromax

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

Other Names:

epoetin alfa

Active Comparator: EPREX

Janssen-Cilag Recombinant Human Erythropoietin (EPREX)

Drug: Eprex

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

Other Names:

epoetin alfa

Outcome Measures

Primary Outcome Measures

Pharmacokinetic - rHuEPO concentration. [Before administration (0h) and after 2h, 4h, 6h, 8h, 10h, 11h, 12h, 13h, 18h, 24h, 36h, 48h, 72h, 96h and 120h administration.]
Will evaluated through the plasma rHuEPO dosage before and after drug administration.
Pharmacodynamics - Absolute Reticulocyte Count. [Before administration (0h) and after 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h and 576h administration.]
Will evaluated through the absolute reticulocyte count at total blood.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.