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

Azidus

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Interferon beta-1a

Study type

Interventional

Funder types

Industry

Identifiers

NCT01074593

VERSION 3

INTBER0609

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.