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

NCT ID: NCT01664195

Last Updated: 2012-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-10-31

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 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.

Conditions

Healthy

Keywords

subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Epoetin alfa Test drug in the first period and comparator drug in the second period.

Group Type: OTHER

Epoetin Alfa

Intervention Type: DRUG

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.

Group B

Epoetin alfa Comparator Drug in the first period and test drug in the second period

Group Type: OTHER

Epoetin Alfa

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Eritromax; Eprex

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LAL Clínica

Valinhos, São Paulo, Brazil

Countries

Brazil

Central Contacts

Alexandre Frederico

Role: CONTACT

Phone: +55 11 38716399

Email: alexandre@lalclinica.com.br

Facility Contacts

Bruna Franco

Role: primary

Nathália Ribeiro

Role: backup

Other Identifiers

Version 1 01/03/2012

Identifier Type: OTHER

Identifier Source: secondary_id

EPOBLA0312IV-I

Identifier Type: -

Identifier Source: org_study_id