Status:
COMPLETED
Comparative Pharmacokinetics and Pharmacodynamics of Peginterferon BIP48 and 40kDa in Healthy Volunteers
Lead Sponsor:
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Conditions:
Chronic Viral Hepatitis C
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy volunteers." This ...
Detailed Description
Double-blind study, ie, the volunteers and the study team will not be aware of the product administered. As the presentations of the two products are different, only the professional who will administ...
Eligibility Criteria
Inclusion
- No history of chronic diseases;
- Preserved oral health;
- No history of acute illness in the last 30 days;
- Absence of significant clinical symptoms and signs on physical examination;
- laboratory tests within normal limits;
- imaging tests within normal limits;
- Seronegative tests for HIV and B and C Hepatitis; Signing the consent form;
- Male;
- Age between 18 and 35 years;
- Body mass index between 19 and 26 (weight in kg / height in meters squared).
Exclusion
- Patients with hypersensitivity to Interferon alpha, Escherichia coli-derived products, polyethylene glycol (macrogol), or any constituent salts of these preparations.
- Individuals treated with some type of interferon at any time, prior to the present research.
- History of chronic diseases such as autoimmune diseases, liver failure, decompensated cirrhosis, heart disease, renal failure, diabetes mellitus, thyroid diseases, hemoglobinopathies, cytopenias, history of psychiatric disease, retinopathy, optic neuritis.
- History of acute viral disease in the last 30 days;
- Current use of medications that alter immunity: corticosteroids, immunosuppressants;
- History of known allergy to drugs, including interferon or to any component of the product (at the discretion of the investigator);
- Having undergone surgery during the 6 months prior to study entry; Had donated blood three months prior to study entry;
- History of alcoholism or current use of alcohol;
- Use of other illicit drugs in the past 6 months;
- Participation in a clinical study with previous therapeutic intervention in the year prior to inclusion.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01889849
Start Date
October 1 2010
End Date
August 1 2011
Last Update
July 1 2013
Active Locations (1)
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1
Bio-Manguinhos/Fiocruz
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-360