Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A

NCT01228422 | Completed

• 1 other identifier: INT2ABLA0908
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Will be studied 24 subjects divided Research and 2 parallel groups; The treatment is a dose of 3MUI of alpha interferon 2nd; There will be collection of blood at times: 0, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours.; The volunteers will be hospitalized 24 hours.; Will be measured labels the AUC, Tmax, Cmax, neopterin and beta2-microglobulin

Outcome Measures

Primary Outcomes (1)

• Evaluate in parallel pharmacodynamic parameters and pharmacokinetics.

  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.

  96 hours.

Secondary Outcomes (1)

• Evaluation of clinical safety through a comparison of clinical and laboratory parameters pre-and post-study and the incidence of adverse events

  96 hours.

Study Arms (2)

1

test interferon - blausiegel

Biological: Interferon alpha 2a

2

reference interferon - Roferon A (Roche)

Biological: Interferon alpha 2a

Interventions

Interferon alpha 2a BIOLOGICAL

3MUI

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Interventions

Interferon alpha-2

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Alexandre Frederico, Doctor

  Azidus Brasil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 26, 2010
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 26, 2010

Record last verified: 2009-03

Locations

BR (1)