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
This study has been completed.
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01074593
First received: November 13, 2009
Last updated: February 22, 2013
Last verified: February 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Interferon beta-1a |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Primary Outcome Measures:
- Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. [ Time Frame: 168 hours ] [ Designated as safety issue: No ]Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification
Secondary Outcome Measures:
- Security: observation of adverse effects [ Time Frame: 168 hours ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Test
Bergamo - Interferon beta-1a
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01074593
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074593
Locations
| Brazil | |
| Lal Clinica Pesquisa E Desenvolvimento Ltda | |
| Valinhos, SP, Brazil, 13270000 | |
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
More Information
No publications provided
| Responsible Party: | Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda |
| ClinicalTrials.gov Identifier: | NCT01074593 History of Changes |
| Other Study ID Numbers: | INTBER0609, VERSION 3 |
| Study First Received: | November 13, 2009 |
| Last Updated: | February 22, 2013 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A |
Additional relevant MeSH terms:
|
Interferon beta 1a Interferon-beta Interferons Adjuvants, Immunologic Anti-Infective Agents Antineoplastic Agents |
Antiviral Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015