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

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01074593
First received: November 13, 2009
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Healthy
Biological: Interferon beta-1a
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. [ Time Frame: 168 hours ] [ Designated as safety issue: No ]
    Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification


Secondary Outcome Measures:
  • Security: observation of adverse effects [ Time Frame: 168 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074593

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01074593     History of Changes
Other Study ID Numbers: INTBER0609, VERSION 3
Study First Received: November 13, 2009
Last Updated: February 22, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A

Additional relevant MeSH terms:
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 17, 2014