[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604027":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":41,"overallOfficials":20,"centralContacts":51,"locations":57,"responsibleParty":74,"collaborators":20,"id":76,"slug":20,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":20,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":20,"studyType":89,"phases":90,"briefSummary":79,"conditions":92,"keywords":20,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Area under the plasma drug concentration-time curve [AUCt]","Area under the plasma drug concentration-time curve \\[AUCt\\] of DWJ1511 and DWC202501","0-12 Hours",{"measure":14,"description":15,"timeFrame":12},"Maximum plasma concentration [Cmax]","Maximum plasma concentration \\[Cmax\\] of DWJ1511 and DWC202501",[17],{"measure":18,"description":19,"timeFrame":12},"Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]","Area under the plasma drug concentration-time curve from time 0 to infinity \\[AUCinf\\] of DWJ1511 and DWC202501",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.",[29,36],{"label":30,"type":31,"description":32,"interventionNames":33},"A(RT)","EXPERIMENTAL","30 Subjects, Cross-over, Single dose DWC202501 on period 1, Single dose of DWJ1511 on period 2",[34,35],"Drug: DWJ1511","Drug: DWC202501",{"label":37,"type":38,"description":39,"interventionNames":40},"B(TR)","ACTIVE_COMPARATOR","30 Subjects, Cross-over, Single dose DWJ1511 on period 1, Single dose of DWC202501 on period 2",[34,35],[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":20},"DRUG","DWJ1511","Test drug: DWJ1511",[30,37],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":20},"DWC202501","Comparator: DWC202501",[30,37],[52],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Kang","CONTACT","82) 070-4665-9490","juspa@newyjh.com",[58],{"facility":59,"status":60,"city":61,"state":20,"zip":62,"country":63,"countryCode":20,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"H Plus Yangji Hospital","RECRUITING","Seoul","08779","South Korea",{"type":65,"coordinates":66},"Point",[67,68],126.9784,37.566,{"lat":68,"lon":67},[71],{"name":53,"role":54,"phone":72,"phoneExt":20,"email":73},"82) 070-4665-9476","juspa@newyji.com",{"type":75,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100604027",false,"NCT07144176","PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers","An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of \"DWJ1511\" and \"DWC202501\" in Healthy Adult Volunteers","Inclusion Criteria:\n\n* Male or female participants aged ≥19 years and \\\u003C65 years at the time of screening\n* Body mass index (BMI) between 18 and 30 kg\u002Fm² (BMI = weight \\[kg\\] \u002F height \\[m\\]²)\n\nExclusion Criteria:\n\n* Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.\n* Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.\n* Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).",true,"ALL","19 Years","64 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1",[93],"Healthy Subjects","2025-08-27",{"date":96,"type":97},"2025-08-28","ACTUAL",{"date":99,"type":88},"2025-09",{"date":99,"type":88},{"name":5,"class":6},1]