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

Tracking Information
First Submitted Date ICMJE	July 25, 2012
First Posted Date ICMJE	August 14, 2012
Last Update Posted Date	August 14, 2012
Study Start Date ICMJE	February 2013
Estimated Primary Completion Date	October 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 10, 2012)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects.
Official Title ICMJE	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.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Healthy
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 10, 2012)	80
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	October 2013
Estimated Primary Completion Date	October 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Male
Ages	20 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01664221
Other Study ID Numbers ICMJE	EPOBLA0412IV-I; Version 1 09/04/2012 ( Other Identifier: LAL Clinica )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Azidus Brasil
Study Sponsor ICMJE	Azidus Brasil
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Azidus Brasil
Verification Date	August 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP