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

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.

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.