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

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Azidus Brasil

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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