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PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Azidus Brasil.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Azidus Brasil Identifier:
First received: July 25, 2012
Last updated: August 10, 2012
Last verified: August 2012
The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.

Condition Intervention Phase
Drug: Epoetin Alfa
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.

Resource links provided by NLM:

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • rHuEPO serum concentration [ Time Frame: 1, 8, 15, 19, 22 and 26 days after first administration ]

    Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration

    Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after administration

  • plasma reticulocyte count. [ Time Frame: 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug. ]

    Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration.

    Time frame on day 29: 72 hours +/- 2 hours after last drug administration.

Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eritromax
Eritromax (Epoetin alfa) intravenous administration, dose: 100 IU/kg
Drug: Epoetin Alfa
Intravenous administration of the drug, test or comparator, for 4 weeks, 3 times a week (monday, wednesday and friday).
Other Names:
  • Eritromax
  • Eprex
Active Comparator: Eprex
Eprex (Epoetin alfa) intravenous administration: 100 IU/kg
Drug: Epoetin Alfa
Intravenous administration of the drug, test or comparator, for 4 weeks, 3 times a week (monday, wednesday and friday).
Other Names:
  • Eritromax
  • Eprex


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Agree to all the purposes of the study by signing and dating the Informed Consent;
  • Male, aged between 20 and 55 years, clinically healthy;
  • BMI between 18.5 and 30;
  • Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
  • VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
  • Human serum ferritin between 36-262 mcg / L;
  • Counting of reticulocytes in peripheral blood ≤ 3%;
  • Serum erythropoietin < 30 mIU / mL.

Exclusion Criteria:

  • Participation in clinical trials in the 12 months preceding the survey;
  • Body weight > 100 kg;
  • Presence of iron deficiency anemia;
  • Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
  • Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
  • Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
  • Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
  • Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
  • Clinical history of autoimmune or hereditary anemia;
  • Clinical history of chronic bleeding;
  • Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
  • Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
  • Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
  • Prior therapies with erythropoietin;
  • Albumin below 3.5 g/dL or higher than 4.8 g/dL;
  • Signs or clinical history of bone marrow aplasia;
  • History and clinical or laboratory liver disease;
  • History and clinical or laboratory nephropathy;
  • Principal Investigator of the study criteria.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01664221

Contact: Alexandre Frederico +55 19 38716399

LAL Clinica Not yet recruiting
Valinhos, Sao Paulo, Brazil, 13276-245
Contact: Bruna Franco    +55 19 38716399   
Contact: Nathália Ribeiro    +55 19 38716399   
Principal Investigator: Alexandre Frederico         
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Azidus Brasil Identifier: NCT01664221     History of Changes
Other Study ID Numbers: EPOBLA0412IV-I
Version 1 09/04/2012 ( Other Identifier: LAL Clinica )
Study First Received: July 25, 2012
Last Updated: August 10, 2012

Keywords provided by Azidus Brasil:

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics processed this record on April 25, 2017