[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-to-severe-benign-prostatic-hyperplasia-bph\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-to-severe-benign-prostatic-hyperplasia-bph":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},44,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","To evaluate and compare the safety and pharmacokinetic profiles of \"AJU-G721\" (test drug) and \"G721R\" (reference drug) in healthy adult male subjects.",[28],"Moderate-to-severe Benign Prostatic Hyperplasia (BPH)","RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2026-07",{"name":39,"class":40},"AJU Pharm Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":26,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":41},"100643505","phase-1-bioequivalence-study-of-aju-g721-and-g721r-in-healthy-adult-volunteers-under-fed-conditions-100643505","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",{"count":49,"type":22},36,[25],[28],"NOT_YET_RECRUITING","2026-06-08",{"date":55,"type":33},"2026-06-11",{"date":37,"type":22},{"date":58,"type":22},"2026-08",{"name":39,"class":40}]