Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Interferon alpha 2a (Biological)
Phase: N/A
Status: Completed
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda. Official(s) and/or principal investigator(s): Alexandre Frederico, Doctor, Principal Investigator, Affiliation: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Summary
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).
Clinical Details
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
Study design: Time Perspective: Prospective
Primary outcome: Evaluate in parallel pharmacodynamic parameters and pharmacokinetics.
Secondary outcome: Evaluation of clinical safety through a comparison of clinical and laboratory parameters pre-and post-study and the incidence of adverse events
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Accepting the End of Free and Informed Consent;
- Research subjects were male, aged 18 to 55 years;
- Research subjects with body mass index ≥ 19 and ≤ 30;
- Be considered healthy, from the analysis of medical history, medical examination and
laboratory tests within the normal range.
Exclusion Criteria:
- Results of laboratory tests outside the values considered acceptable in accordance
with the criteria of medical evaluator;
- Having participated in any experimental study or have ingested any experimental drug
in the last three months before the start of the study;
- Have made regular use of medication in the past 4 weeks preceding the start of the
study or have made use of any medication a week before the start of the study;
- Have been hospitalized for any reason, up to 8 weeks before the start of the study;
- Present history of abuse of alcohol, drugs or medications, or have ingested alcohol
within 48 hours prior to the period of stay;
- Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or
psychiatric;
- Present pressure changes of any cause that requires pharmacological treatment;
present history of myocardial infarction, angina and / or heart failure;
- Have donated or lost 450 ml of blood or more in the three months preceding the study
Locations and Contacts
Lal Clinica Pesquisa E Desenvolvimento Ltda, Valinhos, Sao Paulo 13270000, Brazil
Additional Information
Starting date: March 2009
Last updated: October 25, 2010
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