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

August 10, 2012 updated by: Azidus Brasil

Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Eritromax (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Single Dose, Intravenous Administration in Healthy Subjects: a Randomized 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 single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration of 100 IU/kg in healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • São Paulo
      • Valinhos, São Paulo, Brazil, 13276-245
        • LAL Clínica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group A
Epoetin alfa Test drug in the first period and comparator drug in the second period.
Drug: Epoetin Alfa
Intravenous single-dose administration of 100 IU/kg of the test drug (Eritromax) in the first period and intravenous single-dose administration of 100 IU/kg of the comparator drug (Eprex) in the second period, after 23-30 days of washout, or vice-versa.
Other Names:
  • Eprex
  • Eritromax
Other: Group B
Epoetin alfa Comparator Drug in the first period and test drug in the second period
Drug: Epoetin Alfa
Intravenous single-dose administration of 100 IU/kg of the test drug (Eritromax) in the first period and intravenous single-dose administration of 100 IU/kg of the comparator drug (Eprex) in the second period, after 23-30 days of washout, or vice-versa.
Other Names:
  • Eprex
  • Eritromax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
rHuEPO serum concentration
Time Frame: 0, 10, 20, 30, 40, 50 minutes 1, 2, 4, 6, 8, 10, 12, 24, 36 e 48 hours after drug 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 last drug administration.
0, 10, 20, 30, 40, 50 minutes 1, 2, 4, 6, 8, 10, 12, 24, 36 e 48 hours after drug 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.
1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPOBLA0312IV-I
  • Version 1 01/03/2012 (Other Identifier: LAL Clinica)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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