Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 9:30 AM
Study NCT ID:
NCT01000467
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2009-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study for Probucol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011341', 'term': 'Probucol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2009-10-18', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PK assessment for healthy male volunteer', 'Healthy male subjects aged 20 to 40 years'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.', 'detailedDescription': 'To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Korean\n* Male\n* Age from 20 to 40 years at time of informed consent\n* BMI more than 19.0 and less than 25.0\n* Subjects who meet the following criteria at the time of the screening\n* Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values\n\nExclusion criteria\n\n* History or clinical evidence of significant medical history\n* Present or previous significant drug allergy to any prescription or OTC medication'}, 'identificationModule': {'nctId': 'NCT01000467', 'briefTitle': 'Pharmacokinetics Study for Probucol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '009-KOB-0801i'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Group 2(probucol 500mg BID)', 'interventionNames': ['Drug: probucol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Group 1(Probucol 250mg)', 'interventionNames': ['Drug: probucol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Group 3(Probucol 500mg once daily)', 'interventionNames': ['Drug: probucol']}], 'interventions': [{'name': 'probucol', 'type': 'DRUG', 'otherNames': ['Brand name: Lorelco'], 'description': 'group 3: 250 mg 1 tablet in the morning and evening', 'armGroupLabels': ['3']}, {'name': 'probucol', 'type': 'DRUG', 'otherNames': ['lorelco'], 'description': 'group 1: 250 mg', 'armGroupLabels': ['1']}, {'name': 'probucol', 'type': 'DRUG', 'otherNames': ['Lorelco'], 'description': 'group 2: 250 mg 2 tablets at once in the morning', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national univeristy', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Sang Yoo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Trial Center, Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}