Healthy Clinical Trial
Official title:
Study of Pharmacokinetics and Pharmacodynamics of Alpha Interferon-2A of Blausiegel Trade and Industry the Compared the Product Roferon A, of Laboratory of Roche
The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon alpha-2A - Roche Laboratory).
The Interferons (IFNs) are a group of cytokines produced by vertebrates in response to
various stimuli, including the presence of foreign nucleic acids in the body, bacteria,
tumor cells and viral antigens. These proteins have significant shares immunomodulatory,
antiproliferative and antiviral drugs, the first line of defense of the body. Once produced,
the IFNs block viral replication, maximize the lytic activity of natural killer cells,
increase the expression of MHC class I in cells infected by viruses and induce the
development of Th1 cells The production of interferon alpha-2A is now held by biotechnology
with the establishment of a chain of DNA producer of interferon alpha-2a in the chain of
original DNA of a bacterium, allowing the bacteria produce this drug on an industrial scale.
In the process of synthesis, the 165 amino acids that are part of this molecule can change
in your order with no reduction in activity or changes in the properties.
Due to this fact, the biological and medicinal considered, especially those in manufacturing
by genetic engineering, need to prove their clinical activity so that they can be marketed.
In the case of interferon, the consequences of the use of a product without activity
compared to treat patients with Hepatitis C can lead to serious health complications from
them. It is therefore necessary to prove its clinical activity and pharmacokinetics before
its clinical efficacy. The sponsor of this study aims to end the renewal of registration of
interferon alpha-2A with the Ministry of Health So this study to evaluate the
Pharmacokinetics and Pharmacodynamics of interferon alpha-2a may allow in the future this
medicine can be used by a year in patients with hepatitis C, without risk to their health,
besides those already known and inherent in the treatment of any interferon.
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