[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643505":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":41,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":25,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":25,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"AJU Pharm Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A","EXPERIMENTAL","Period 1: Reference Drug, Single dose\u002F Period 2: Test Drug, Single dose",[13,14],"Drug: Test Drug","Drug: Reference Drug",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence B","Period 1: Test Drug, Single dose\u002F Period 2: Reference Drug, Single dose",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Test Drug","AJU-G721",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Reference Drug","G721R",[9,16],[31],{"facility":32,"status":25,"city":33,"state":25,"zip":25,"country":34,"countryCode":25,"cosmosGeoPoint":35,"geoPoint":40,"contacts":25},"Bumin Hospital","Seoul","South Korea",{"type":36,"coordinates":37},"Point",[38,39],126.9784,37.566,{"lat":39,"lon":38},{"type":42,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100643505","phase-1-bioequivalence-study-of-aju-g721-and-g721r-in-healthy-adult-volunteers-under-fed-conditions-100643505",false,"NCT07643233","Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions","An Open-Label, Randomized, Fed, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of \"AJU-G721\" and \"G721R\" in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Healthy male adults aged ≥19 years and \\\u003C55 years at screening.\n* Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg\u002Fm².\n* Clinically healthy based on medical history, physical examination, ECG, and laboratory test results, as determined by the investigator.\n* Willing and able to provide written informed consent.\n* Agrees to use medically acceptable contraception during the required study period.\n\nExclusion Criteria:\n\n* Use of medications known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or other medications that may interfere with the study within 10 days prior to dosing.\n* Participation in another clinical trial involving an investigational product within 6 months prior to the first dose.\n* Whole blood donation within 8 weeks or component blood donation within 2 weeks prior to the first dose.\n* History of gastrointestinal resection that may affect drug absorption.\n* Known hypersensitivity to dutasteride, tamsulosin, or any component of the investigational product.\n* History of psychiatric illness, or any condition considered unsuitable for study participation by the investigator.",true,"MALE","19 Years","54 Years",{"count":55,"type":56},36,"ESTIMATED","INTERVENTIONAL",[59],"PHASE1","To evaluate and compare the safety and pharmacokinetic profiles of \"AJU-G721\" (test drug) and \"G721R\" (reference drug) in healthy adult male subjects.",[62],"Moderate-to-severe Benign Prostatic Hyperplasia (BPH)","NOT_YET_RECRUITING","2026-06-08",{"date":66,"type":67},"2026-06-11","ACTUAL",{"date":69,"type":56},"2026-07",{"date":71,"type":56},"2026-08",{"name":5,"class":6},1]