[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627111":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":43,"collaborators":24,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":24,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":24,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Addpharma Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A","EXPERIMENTAL","Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg \u002F tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg \u002F tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.",[13],"Drug: AD-116, AD-1161",{"label":15,"type":10,"description":16,"interventionNames":17},"Sequence B","Period 1 : Test Drug(dutasteride 0.5 mg \u002F tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg \u002F tamsulosin 0.4 mg) in Period 2.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","AD-116, AD-1161","Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"JaeHun Jung","CONTACT","+82-31-891-5683","jhjung@addpharma.co.kr",[32],{"facility":33,"status":34,"city":35,"state":24,"zip":24,"country":36,"countryCode":24,"cosmosGeoPoint":37,"geoPoint":42,"contacts":24},"H PLUS YANGJI HOSPITAL, Seoul","RECRUITING","Seoul","South Korea",{"type":38,"coordinates":39},"Point",[40,41],126.9784,37.566,{"lat":41,"lon":40},{"type":44,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100627111","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-ad-116-and-ad-1161-in-healthy-adult-male-subjects-100627111",false,"NCT07444385","A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects","An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Period Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions","Inclusion Criteria:\n\n* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg\u002Fm2 and 30.0 kg\u002Fm2 at the time of screening visit\n* The Age equal to or greater than 19 in healthy adult male volunteers at the time of screening visit\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration\n* Other exclusions applied",true,"MALE","19 Years",{"count":56,"type":57},44,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects",[63],"Benign Prostatic Hyperplasia","2026-03-01",{"date":66,"type":67},"2026-03-03","ACTUAL",{"date":69,"type":67},"2026-02-26",{"date":71,"type":57},"2026-05-08",{"name":5,"class":6},1]