Completed

Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.

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What is being tested

Epoetin Alfa

+ Epoetin Alfa

Drug
Who is being recruted

From 20 to 55 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorAzidus Brasil
Last updated: October 28, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: February 28, 2013

Actual date on which the first participant was enrolled.

The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) 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 Human Reconbiant Epoetin produced 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.

NCT01685359
Principal SponsorAzidus Brasil
Last updated: October 28, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

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

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Agree to all the purposes of the study by signing and dating the Informed Consent
BMI between 18.5 and 30
Counting of reticulocytes in peripheral blood <= 3%
Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%
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19 exclusion criteria prevent from participating
Acute disease in the period of 07 days before 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
Albumin below 3.5 g/dL or higher than 4.8 g/dL
Body weight > 100 kg
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Test Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration

Group II

Active Comparator
Eprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

LAL Clinica

Valinhos, BrazilOpen LAL Clinica in Google Maps
CompletedOne Study Center