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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01074593 |
Recruitment Status :
Completed
First Posted : February 24, 2010
Last Update Posted : February 25, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Biological: Interferon beta-1a | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. [ Time Frame: 168 hours ]Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification
- Security: observation of adverse effects [ Time Frame: 168 hours ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074593
Brazil | |
Lal Clinica Pesquisa E Desenvolvimento Ltda | |
Valinhos, SP, Brazil, 13270000 |
Responsible Party: | Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda |
ClinicalTrials.gov Identifier: | NCT01074593 |
Other Study ID Numbers: |
INTBER0609 VERSION 3 |
First Posted: | February 24, 2010 Key Record Dates |
Last Update Posted: | February 25, 2013 |
Last Verified: | February 2013 |
PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A |
Interferons Interferon-beta Interferon beta-1a Antineoplastic Agents Antiviral Agents |
Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |