Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A
Lead Sponsor:
Azidus Brasil
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Brief 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).
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01228422
Start Date
March 1 2009
End Date
August 1 2009
Last Update
October 26 2010
Active Locations (1)
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1
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000