- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01685359
PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Sao Paulo
-
Valinhos, Sao Paulo, Brazil, 13276-245
- LAL Clínica
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Test Drug
Test Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration
|
Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
Other Names:
|
ACTIVE_COMPARATOR: Eprex
Eprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration
|
Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 last drug administration. |
1, 8, 15, 19, 22 and 26 days after first 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 frameon day 29: 72h +/- 2h 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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPOBLA0612IV-I2
- Version 1 25/06/2012 (OTHER: 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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