Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00689858
Status:
COMPLETED
Last Update Posted:
2009-01-13
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}, {'id': 'D000096983', 'term': 'Ginkgo Extract'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concetration of Cilostazol at steady state', 'timeFrame': 'within 12hrs after cilostazol'}], 'secondaryOutcomes': [{'measure': 'PD parameter: change from baseline after administration (change value of aggregation %)', 'timeFrame': 'within 12hrs after cilostazol'}]}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula.\n* the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.\\]\n\nExclusion Criteria:\n\n* the subject who has abnornal lab. ( In particular, AST or ALT \\> 1.25 times of upper limit / Total bilirubin \\> 1.5 times of upper limit/170,000 \\< Platelet \\< 360,000 / PT or aPTT or BT\\> \\>upper limit\n* the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study."}, 'identificationModule': {'nctId': 'NCT00689858', 'briefTitle': 'Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'Clinical Trial to Assessment the PK/PD Characteristics and Safety After co-Administration of Cilostazol With Ginkgo Biloba or Placebo in Healthy Subject.', 'orgStudyIdInfo': {'id': 'GETC_DDI_I_2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Period 1: Cilostazol, Ginkgo biloba Period 2:Cilostazol, placebo', 'interventionNames': ['Drug: Cilostazol, Ginkgo biloba and placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Period 1: Cilostazol, placebo Period 2: Cilostazol, Ginkgo biloba', 'interventionNames': ['Drug: Cilostazol, Ginkgo biloba and placebo']}], 'interventions': [{'name': 'Cilostazol, Ginkgo biloba and placebo', 'type': 'DRUG', 'description': 'dosing time', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pusan', 'country': 'South Korea', 'facility': 'INJE University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SK chemicals', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'SKChemicals', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae Gook Shin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Research Team Organization: SK Chemicals Co.,Ltd.', 'oldOrganization': 'SK Chemicals Co.,Ltd.'}}}}