Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A (interferon)

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01228422
First received: October 21, 2008
Last updated: October 25, 2010
Last verified: March 2009

October 21, 2008
October 25, 2010
March 2009
August 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01228422 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A
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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Healthy volunteers

Healthy
Biological: Interferon alpha 2a
3MUI
  • 1
    test interferon - blausiegel
    Intervention: Biological: Interferon alpha 2a
  • 2
    reference interferon - Roferon A (Roche)
    Intervention: Biological: Interferon alpha 2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01228422
INT2ABLA0908
No
Alexandre Frederico, LAL Clinica
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Not Provided
Principal Investigator: Alexandre Frederico, Doctor L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP