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 because the information has not been verified recently.
Verified August 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01664221
First received: July 25, 2012
Last updated: August 10, 2012
Last verified: August 2012

July 25, 2012
August 10, 2012
February 2013
October 2013   (final data collection date for primary outcome measure)
  • rHuEPO serum concentration [ Time Frame: 1, 8, 15, 19, 22 and 26 days after first administration ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]

    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.

Same as current
Complete list of historical versions of study NCT01664221 on ClinicalTrials.gov Archive Site
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PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects.
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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
  • Experimental: Eritromax
    Eritromax (Epoetin alfa) intravenous administration, dose: 100 IU/kg
    Intervention: Drug: Epoetin Alfa
  • Active Comparator: Eprex
    Eprex (Epoetin alfa) intravenous administration: 100 IU/kg
    Intervention: Drug: Epoetin Alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Male
20 Years to 55 Years
Yes
Contact: Alexandre Frederico +55 19 38716399 alexandre@lalclinica.com.br
Brazil
 
NCT01664221
EPOBLA0412IV-I, Version 1 09/04/2012
Yes
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Not Provided
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP