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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Interferon beta-1a; Biological: Interferon beta-1a

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Valinhos, SP, Brazil, 13270000
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Bergamo - Interferon beta-1a	Biological: Interferon beta-1a; 12.000UI - single dose; 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; Biological: Interferon beta-1a; 12.000UI - Single dose

What is the study measuring?

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	Time Frame
Security: observation of adverse effects	168 hours

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: INTBER0609; version 3 (Protocol Version)