[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598272":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":26,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":26,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":36,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1 (TR)","EXPERIMENTAL","Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 1, subjects receive T (1d-7d) then R (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None",[13],"Drug: Olaparib 150 MG",{"label":15,"type":10,"description":16,"interventionNames":17},"Sequence 2 (RT)","Subjects are randomized into two sequence groups (Sequence 1 and 2). In Sequence 2, subjects receive R (1d-7d) then T (8d-14d) T: Test treatment BR2022 (Olaparib 150.00mg) R: Reference treatment BR2022-1 (Olaparib 150 mg) Washout interval: None",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Olaparib 150 MG","Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration",[9,15],[25],"BR2022",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Shinyoung Oh","CONTACT","+82 2-708-8000","syoh@boryung.co.kr",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":26,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Asan Medical Center","RECRUITING","Seoul","Songpa District","05505","South Korea",{"type":42,"coordinates":43},"Point",[44,45],126.9784,37.566,{"lat":45,"lon":44},[48],{"name":26,"role":30,"phone":49,"phoneExt":26,"email":26},"01034379425",{"type":51,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100598272","phase-1-a-bioequivalence-study-to-evaluate-pharmacokinetics-and-safety-of-br2022-and-br2022-1-in-patients-with-deleterious-or-suspected-deleterious-germline-brca-mutated-advanced-ovarian-cancer-100598272",false,"NCT07069335","A Bioequivalence Study to Evaluate Pharmacokinetics and Safety of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer","A Multi-centre, Open-Label, Randomized, Two-Stage, Two-treatment, Two-Period, Multiple-Dose, Crossover Bioequivalence Study to Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2022 and BR2022-1 in Patients With Deleterious or Suspected Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer","Inclusion Criteria:\n\n1. Females aged 19 -74 at the time of consent\n2. Those who voluntarily signed the informed consent to participate in this study\n3. Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been taking stable doses of olaparib for more than 3 months before screening.\n\nExclusion Criteria:\n\n1. Those who have a history of severe hypersensitivity to drugs that include the ingredients of the investigational product or have a history of clinically significant hypersensitivity reactions\n2. Those who have gastrointestinal disorders (e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or have had surgeries (excluding appendectomy or hernia surgery) that may affect the absorption of the investigational products\n3. Those who are pregnant, suspected of pregnancy, or nursing","FEMALE","19 Years","74 Years",{"count":63,"type":64},24,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This was a multicenter, open-label, randomized, crossover bioequivalence study to evaluate the pharmacokinetics and safety of BR2022 and BR2022-1 in Patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer.",[70],"Ovarian Cancer",[72,70,25],"BRCA-mutated","2025-07-07",{"date":75,"type":76},"2025-07-16","ACTUAL",{"date":78,"type":76},"2025-06-17",{"date":80,"type":64},"2026-05-15",{"name":5,"class":6},1]