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Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01074593
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by:
Azidus Brasil

Study Description
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Brief Summary:
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).

Condition or disease Intervention/treatment Phase
Healthy Biological: Interferon beta-1a Phase 1

Detailed Description:
Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Clinical Study of Pharmacokinetics and Pharmacodynamics of the Drug Interferon Beta-1a Produced By Laboratorio Quimico Farmaceutico Bergamo Compared To Interferon Beta-1a (Rebif - Merck Serono) In Healthy Subjects
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Test
Bergamo - Interferon beta-1a
 Biological: Interferon beta-1a
12.000UI - single dose
Active Comparator: Comparator - Merck Serono
Merck Serono - Interferon beta-1a
 Biological: Interferon beta-1a
12.000UI - Single dose


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. [ Time Frame: 168 hours ]
    Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification


Secondary Outcome Measures :
  1. Security: observation of adverse effects [ Time Frame: 168 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Accepted Informed Consent
  2. Study subjects male, aged 18 to 50 years;
  3. Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
  4. Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.

Exclusion Criteria:

  1. Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
  2. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
  3. Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study;
  4. Have been hospitalized for any reason, up to 8 weeks before the start of the study;
  5. Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
  6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
  7. To present the pressure of any etiology requiring pharmacological treatment;
  8. Display history of myocardial infarction, angina and / or heart failure.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074593


Locations
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Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
More Information
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Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01074593    
Other Study ID Numbers: INTBER0609
VERSION 3
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by Azidus Brasil:
PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A
Additional relevant MeSH terms:
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Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
 Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic