[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643125":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":48,"collaborators":25,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":25,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"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":33,"city":34,"state":25,"zip":25,"country":35,"countryCode":25,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Bumin Hospital","RECRUITING","Seoul","South Korea",{"type":37,"coordinates":38},"Point",[39,40],126.9784,37.566,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Jaewan Jeong","CONTACT","+82-1577-7582","jaewan88@bumin.co.kr",{"type":49,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100643125","phase-1-bioequivalence-study-of-aju-g721-and-g721r-in-healthy-adult-volunteers-under-fasting-conditions-100643125",false,"NCT07643220","Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fasting Conditions","An Open-Label, Randomized, Fasting, 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":62,"type":63},44,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","To evaluate and compare the safety and pharmacokinetic profiles of \"AJU-G721\" (test drug) and \"G721R\" (reference drug) in healthy adult male subjects.",[69],"Moderate-to-severe Benign Prostatic Hyperplasia (BPH)","2026-06-10",{"date":72,"type":73},"2026-06-12","ACTUAL",{"date":75,"type":63},"2026-06",{"date":77,"type":63},"2026-07",{"name":5,"class":6},1]