[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610767":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":25,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":25,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"AJU Pharm Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Pranlukast Test Formulation","EXPERIMENTAL","Two-period, single-dose, crossover study",[13,14],"Drug: AJU-R713","Drug: R713R",{"label":16,"type":10,"description":17,"interventionNames":18},"Pranlukast Reference Formulation","Two-period, single-dose, crossover study (reversed order)",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AJU-R713","Oral formulation",[16,9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"R713R",[16,9],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Heejoo Hong","CONTACT","+82-70-4665-9156","m4688@newyjh.com",[36],{"facility":37,"status":25,"city":38,"state":25,"zip":39,"country":40,"countryCode":25,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"H Plus Yangji Hospital","Seoul","08779","South Korea",{"type":42,"coordinates":43},"Point",[44,45],126.9784,37.566,{"lat":45,"lon":44},{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100610767","phase-1-bioequivalence-study-of-aju-r713-and-r713r-in-healthy-adult-volunteers-100610767",false,"NCT07231861","Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers","An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of \"AJU-R713\" and \"R713R\" in Healthy Adult Volunteers","Inclusion Criteria:\n\n* Healthy adults aged 19 years or older at the time of screening.\n* Body mass index (BMI) between 18 and 30 kg\u002Fm².\n\n  * Male subjects: body weight ≥ 50 kg.\n  * Female subjects: body weight ≥ 45 kg.\n* Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator.\n* Willing and able to provide written informed consent after receiving a full explanation of the study.\n* Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose.\n\nExclusion Criteria:\n\n* Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.\n* Participation in any clinical trial involving investigational products 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 surgery that may affect drug absorption (excluding appendectomy and hernia repair).\n* Known hypersensitivity to the investigational product or its components.\n* Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria.\n* History of clinically significant psychiatric illness.\n* Pregnant or breastfeeding women, or women with a possibility of pregnancy.",true,"ALL","19 Years",{"count":60,"type":61},60,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.",[67,68],"Bronchial Asthma","Perennial Allergic Rhinitis","NOT_YET_RECRUITING","2025-11-16",{"date":72,"type":73},"2025-11-19","ACTUAL",{"date":75,"type":61},"2025-12",{"date":75,"type":61},{"name":5,"class":6},1]