Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-03-02 @ 8:38 AM
Study NCT ID:
NCT01421706
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-16', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effects of clopidogrel and clarithromycin on the disposition of sibutramine', 'timeFrame': 'one year', 'description': 'the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6\\*6 genetic polymorphism have been evaluated in Korean healthy subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clarithromycin', 'sibutramine', 'clopidogrel'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects', 'detailedDescription': '1\\. Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6\\*1/\\*1, \\*1/\\*6 and \\*6/\\*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be healthy volunteer\n\nExclusion Criteria:\n\n* must not be under 18 years old'}, 'identificationModule': {'nctId': 'NCT01421706', 'acronym': 'sibu', 'briefTitle': 'Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism', 'orgStudyIdInfo': {'id': '08-073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sibutramine-clopidogrel', 'description': 'sibutramine-clopidogrel', 'interventionNames': ['Drug: Sibutramine-clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sibutramine-clarithromycin', 'description': 'sibutramine-clarithromycin', 'interventionNames': ['Drug: sibutramine-Clarithromycin']}], 'interventions': [{'name': 'Sibutramine-clopidogrel', 'type': 'DRUG', 'description': 'Sibutramine-clopidogrel', 'armGroupLabels': ['sibutramine-clopidogrel']}, {'name': 'sibutramine-Clarithromycin', 'type': 'DRUG', 'description': 'sibutramine-Clarithromycin', 'armGroupLabels': ['sibutramine-clarithromycin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'JaeGook Shin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Gook Shin', 'investigatorAffiliation': 'Inje University'}}}}