[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503241":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":39,"locations":40,"responsibleParty":53,"collaborators":39,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":39,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":39,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":39,"overallStatus":74,"whyStopped":39,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A","ACTIVE_COMPARATOR","P1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg",[13],"Drug: Ursodeoxycholic Acid 250 Mg Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment B","P1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Treatment C","P1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Treatment D","P1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Ursodeoxycholic Acid 250 Mg Oral Tablet","Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet",[9,15,19,23],[33],"Ursodeoxycholic Acid 100 Mg Oral Tablet",[35],{"name":36,"affiliation":37,"role":38},"BoHyung Kim\u003Cbhkim98@gmail.com> Kim, MD, PhD","Kyung Hee University Hospital","PRINCIPAL_INVESTIGATOR",null,[41],{"facility":42,"status":39,"city":43,"state":44,"zip":45,"country":46,"countryCode":39,"cosmosGeoPoint":47,"geoPoint":52,"contacts":39},"Kyung Hee University Medical Hospital","Seoul","Korea, Republic of","02447","South Korea",{"type":48,"coordinates":49},"Point",[50,51],126.9784,37.566,{"lat":51,"lon":50},{"type":54,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100503241","phase-1-an-exploratory-clinical-trial-to-evaluate-and-compare-safety-and-pharmacokinetic-characteristics-after-administration-of-the-dwj1439-dwj1464-dwc202108-or-dwc202109-in-healthy-adult-volunteers-100503241",false,"NCT05832697","An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers","Inclusion Criteria:\n\n* Healthy adult volunteers aged 19 years old to under 55.\n* BMI 18.0≥ and ≤30 kg\u002Fm² with body mass ≥50 kg\n* Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.\n* Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).\n* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.\n\nExclusion Criteria:\n\n* Known history or presence of any clinically significant medical condition. Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.\n* Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.\n* Refusal to abstain from caffeine or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.\n* Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.",true,"ALL","19 Years","55 Years",{"count":66,"type":67},44,"ACTUAL","INTERVENTIONAL",[70],"PHASE1","This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.",[73],"Healthy Subject","COMPLETED","2023-04-16",{"date":77,"type":67},"2023-04-27",{"date":79,"type":67},"2022-01-27",{"date":81,"type":67},"2023-01-30",{"name":5,"class":6},1]