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

NCT01074593 | Completed Phase 1

• 2 other identifiers: INTBER0609VERSION 3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A

Outcome Measures

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

  168 hours

Secondary Outcomes (1)

• Security: observation of adverse effects

  168 hours

Study Arms (2)

Test

EXPERIMENTAL

Bergamo - Interferon beta-1a

Biological: Interferon beta-1a

Comparator - Merck Serono

ACTIVE COMPARATOR

Merck Serono - Interferon beta-1a

Biological: Interferon beta-1a

Interventions

Interferon beta-1a BIOLOGICAL

12.000UI - single dose

Test

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
• Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
• 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;
• Have been hospitalized for any reason, up to 8 weeks before the start of the study;
• Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
• Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
• To present the pressure of any etiology requiring pharmacological treatment;
• Display history of myocardial infarction, angina and / or heart failure.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Interventions

Interferon beta-1a

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: February 24, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

BR (1)