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CompletedNCT01074593Updated Feb 25, 2013

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

A Phase 1 interventional study of Interferon beta-1a and Interferon beta-1a in Healthy, sponsored by Azidus Brasil. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by Azidus Brasil · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A
03

In context

Lead sponsor

Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Test

    Bergamo - Interferon beta-1a

    Biological: Interferon beta-1a

  • Active comparator
    Comparator - Merck Serono

    Merck Serono - Interferon beta-1a

    Biological: Interferon beta-1a

Interventions

  • BiologicalInterferon beta-1a

    12.000UI - single dose

  • BiologicalInterferon beta-1a

    12.000UI - Single dose

06

What researchers measure

Primary outcomes

  1. Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.

    Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification

    Time frame: 168 hours

Secondary outcomes

  1. Security: observation of adverse effects

    Time frame: 168 hours

07

Study locations

1 site
  • Lal Clinica Pesquisa E Desenvolvimento Ltda
    Valinhos, SP 13270000, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01074593
Lead sponsor
Azidus Brasil
First posted
Feb 24, 2010
Start date
Jan 2011
Primary completion
Mar 2011
Completion
Jul 2011
Last update
Feb 25, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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