Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A (interferon)
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).
|Study Design:||Time Perspective: Prospective|
|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|
- Evaluate in parallel pharmacodynamic parameters and pharmacokinetics. [ Time Frame: 96 hours. ] [ Designated as safety issue: No ]Pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.
- Evaluation of clinical safety through a comparison of clinical and laboratory parameters pre-and post-study and the incidence of adverse events [ Time Frame: 96 hours. ] [ Designated as safety issue: Yes ]The pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.
|Study Start Date:||March 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
test interferon - blausiegel
Biological: Interferon alpha 2a
reference interferon - Roferon A (Roche)
Biological: Interferon alpha 2a
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.
|Lal Clinica Pesquisa E Desenvolvimento Ltda|
|Valinhos, Sao Paulo, Brazil, 13270000|
|Principal Investigator:||Alexandre Frederico, Doctor||L.A.L Clinica Pesquisa e Desenvolvimento Ltda.|