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

NCT ID: NCT01074593

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-07-31

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).

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Test

Bergamo - Interferon beta-1a

Group Type: EXPERIMENTAL

Interferon beta-1a

Intervention Type: BIOLOGICAL

12.000UI - single dose

Comparator - Merck Serono

Merck Serono - Interferon beta-1a

Group Type: ACTIVE_COMPARATOR

Interferon beta-1a

Intervention Type: BIOLOGICAL

12.000UI - Single dose

Interventions

Interferon beta-1a

12.000UI - single dose

Intervention Type: BIOLOGICAL

Interferon beta-1a

12.000UI - Single dose

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica Pesquisa e Desenvolvimento Ltda

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

VERSION 3

Identifier Type: -

Identifier Source: secondary_id

INTBER0609

Identifier Type: -

Identifier Source: org_study_id