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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074593
• Other study ID #: INTBER0609
• Secondary ID: VERSION 3
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2009
• Last updated: February 22, 2013
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: February 2013
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Interferon beta-1a
12.000UI - single dose
• Interferon beta-1a
12.000UI - Single dose

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Security: observation of adverse effects		168 hours	No