Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT01074593
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068556', 'term': 'Interferon beta-1a'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2010-02-23', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.', 'timeFrame': '168 hours', 'description': "Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification"}], 'secondaryOutcomes': [{'measure': 'Security: observation of adverse effects', 'timeFrame': '168 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Accepted Informed Consent\n2. Study subjects male, aged 18 to 50 years;\n3. Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;\n4. Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.\n\nExclusion Criteria:\n\n1. Having donated or lost 450 mL or more of blood in the 6 months preceding the study;\n2. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;\n3. 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;\n4. Have been hospitalized for any reason, up to 8 weeks before the start of the study;\n5. Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;\n6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;\n7. To present the pressure of any etiology requiring pharmacological treatment;\n8. Display history of myocardial infarction, angina and / or heart failure.'}, 'identificationModule': {'nctId': 'NCT01074593', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'INTBER0609'}, 'secondaryIdInfos': [{'id': 'VERSION 3'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Bergamo - Interferon beta-1a', 'interventionNames': ['Biological: Interferon beta-1a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator - Merck Serono', 'description': 'Merck Serono - Interferon beta-1a', 'interventionNames': ['Biological: Interferon beta-1a']}], 'interventions': [{'name': 'Interferon beta-1a', 'type': 'BIOLOGICAL', 'description': '12.000UI - single dose', 'armGroupLabels': ['Test']}, {'name': 'Interferon beta-1a', 'type': 'BIOLOGICAL', 'description': '12.000UI - Single dose', 'armGroupLabels': ['Comparator - Merck Serono']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13270000', 'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Lal Clinica Pesquisa E Desenvolvimento Ltda', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Alexandre Frederico', 'oldOrganization': 'LAL Clinica Pesquisa e Desenvolvimento Ltda'}}}}