[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633858":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":36,"overallOfficials":49,"centralContacts":54,"locations":16,"responsibleParty":59,"collaborators":16,"id":61,"slug":16,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":16,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":16,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":16,"overallStatus":79,"whyStopped":16,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":16},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"AUCtau","Area under the plasma concentration-time curve over the dosing interval at steady state","0~12 hours",{"measure":14,"description":15,"timeFrame":12},"Css,max","Maximum observed plasma concentration at steady state",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","A Multi-center, Randomized, Open-Label, Multiple-dose, Two-Stage, Two-treatment, Two-period, Crossover Study",[25,32],{"label":26,"type":27,"description":28,"interventionNames":29},"Experimental group 1","EXPERIMENTAL","Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)",[30,31],"Drug: CKD-215","Drug: D215",{"label":33,"type":27,"description":34,"interventionNames":35},"Experimental group 2","Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)",[30,31],[37,44],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","CKD-215","2 tablets BID at 12-hour intervals for 7 days",[26,33],[43],"TEST drug",{"type":38,"name":45,"description":40,"armGroupLabels":46,"otherNames":47},"D215",[26,33],[48],"Reference drug",[50],{"name":51,"affiliation":52,"role":53},"Jeong-Yeol Park, Ph.D","Asan Medical Center","STUDY_CHAIR",[55],{"name":51,"role":56,"phone":57,"phoneExt":16,"email":58},"CONTACT","82-2-3010-3646","catgut1-0@hanmail.net",{"type":60,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100633858",false,"NCT07532148","Study of CKD-215 and D215 in Adults With BRCA-mutated Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","A Multicenter, Randomized, Open-Label, 2-Period Crossover Study to Evaluate Pharmacokinetics, Safety, and Tolerability of CKD-215 and D215 in Adults With Advanced BRCA-Mutated Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer\n* 18.0kg\u002Fm2≤body mass index(BMI)≤28.0kg\u002Fm2\n\nExclusion Criteria:\n\n* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery\n* Patients with central nervous system metastases, unless clinically stable after treatment\n* CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215\n* Subjects who are unable to participate in this clinical trial at the discretion of the investigator","FEMALE","19 Years","75 Years",{"count":71,"type":72},24,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215",[78],"Ovarian Cancer","NOT_YET_RECRUITING","2026-04-09",{"date":82,"type":83},"2026-04-15","ACTUAL",{"date":85,"type":72},"2026-06",{"date":87,"type":72},"2027-08",{"name":5,"class":6}]