[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561617":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":37,"overallOfficials":52,"centralContacts":57,"locations":16,"responsibleParty":62,"collaborators":16,"id":64,"slug":16,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":16,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":16,"enrollmentInfo":73,"targetDuration":16,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":16,"overallStatus":82,"whyStopped":16,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":16},{"fullName":5,"class":6},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"The maximum serum concentration(Cmax) of DWJ1589 and DWC202315","Cmax of DWJ1589 and DWC202315","At pre-dose (0 hour), and post-dose 0.83 to 72 hour.",{"measure":14,"description":15,"timeFrame":12},"The Area under the curve(AUC)last of DWJ1589 and DWC202315","AUClast of DWJ1589 and DWC202315",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE","The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast\u002FAUCinf, Tmax and t1\u002F2 of DWJ1589 and DWC202315.",[25,34],{"label":26,"type":27,"description":28,"interventionNames":29},"Sequence A: RTRT","EXPERIMENTAL","T: DWJ1589 R: DWC202315",[30,31,32,33],"Drug: Period 1","Drug: Period 2","Drug: Period 3","Drug: Period 4",{"label":35,"type":27,"description":28,"interventionNames":36},"Sequence B: TRTR",[30,31,32,33],[38,43,46,49],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"DRUG","Period 1","DWJ1589 or DWC202315",[26,35],{"type":39,"name":44,"description":41,"armGroupLabels":45,"otherNames":16},"Period 2",[26,35],{"type":39,"name":47,"description":41,"armGroupLabels":48,"otherNames":16},"Period 3",[26,35],{"type":39,"name":50,"description":41,"armGroupLabels":51,"otherNames":16},"Period 4",[26,35],[53],{"name":54,"affiliation":55,"role":56},"KANG, MD, PhD","H Plus Yangji Hospital","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":16,"email":16},"SHIN, CPL","CONTACT","02-550-8858",{"type":63,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100561617",false,"NCT06592495","Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315","Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions","Inclusion Criteria:\n\n* Over 19 year old\n* Healthy adult volunteers\n\nExclusion Criteria:\n\n* with a history of mental disorder\n* For female volunteers, those who are suspected of being pregnant or lactating",true,"ALL","19 Years",{"count":74,"type":75},52,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.",[81],"Healthy Volunteers","NOT_YET_RECRUITING","2024-09-19",{"date":85,"type":86},"2024-09-23","ACTUAL",{"date":88,"type":75},"2024-10",{"date":90,"type":75},"2025-10",{"name":5,"class":6}]