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 Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: Interferon beta-1a
* Biological: Interferon beta-1a


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Bergamo - Interferon beta-1a | Biological: Interferon beta-1a<br>* 12.000UI - single dose<br>|
| Active Comparator: Comparator - Merck Serono<br>Merck Serono - Interferon beta-1a | Biological: Interferon beta-1a<br>* 12.000UI - Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Security: observation of adverse effects |  | 168 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A