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:

ClinicalTrials.gov Identifier:

NCT01074593

First Posted: February 24, 2010

Last Update Posted: February 25, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Azidus Brasil

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 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

Resource links provided by NLM:

Drug Information available for: Interferon Interferon beta Interferon beta-1a Avonex

U.S. FDA Resources

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:

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:

Security: observation of adverse effects [ Time Frame: 168 hours ]


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

Information from the National Library of Medicine

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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:

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.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

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


Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000

Sponsors and Collaborators

Azidus Brasil

More Information


Responsible Party:	Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier:	NCT01074593 History of Changes
Other Study ID Numbers:	INTBER0609 VERSION 3
First Submitted:	November 13, 2009
First Posted:	February 24, 2010
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:


Interferons Interferon-beta Interferon beta-1a Antineoplastic Agents Antiviral Agents	Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic

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