[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643505":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":23,"interventions":35,"overallOfficials":16,"centralContacts":16,"locations":45,"responsibleParty":56,"collaborators":16,"id":58,"slug":16,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":16,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":16,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":16,"overallStatus":77,"whyStopped":16,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"AJU Pharm Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Cmax of Tamsulosin.","To assess the maximum observed plasma concentration (Cmax) of Tamsulosin.","0 hour ~ 48 hour after drug administration",{"measure":14,"description":15,"timeFrame":12},"AUCt of Tamsulosin","To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Tamsulosin",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE",[24,31],{"label":25,"type":26,"description":27,"interventionNames":28},"Sequence A","EXPERIMENTAL","Period 1: Reference Drug, Single dose\u002F Period 2: Test Drug, Single dose",[29,30],"Drug: Test Drug","Drug: Reference Drug",{"label":32,"type":26,"description":33,"interventionNames":34},"Sequence B","Period 1: Test Drug, Single dose\u002F Period 2: Reference Drug, Single dose",[29,30],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":16},"DRUG","Test Drug","AJU-G721",[25,32],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":16},"Reference Drug","G721R",[25,32],[46],{"facility":47,"status":16,"city":48,"state":16,"zip":16,"country":49,"countryCode":16,"cosmosGeoPoint":50,"geoPoint":55,"contacts":16},"Bumin Hospital","Seoul","South Korea",{"type":51,"coordinates":52},"Point",[53,54],126.9784,37.566,{"lat":54,"lon":53},{"type":57,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","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":69,"type":70},36,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","To evaluate and compare the safety and pharmacokinetic profiles of \"AJU-G721\" (test drug) and \"G721R\" (reference drug) in healthy adult male subjects.",[76],"Moderate-to-severe Benign Prostatic Hyperplasia (BPH)","NOT_YET_RECRUITING","2026-06-08",{"date":80,"type":81},"2026-06-11","ACTUAL",{"date":83,"type":70},"2026-07",{"date":85,"type":70},"2026-08",{"name":5,"class":6},1]