[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596385":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":35,"responsibleParty":47,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":26,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"AJU Pharm Co., Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Two-period, single-dose, crossover study",[13,14,15],"Drug: Comparator 1","Drug: Comparator 2","Drug: Test Drug",{"label":17,"type":10,"description":18,"interventionNames":19},"Group B","Two-period, single-dose, crossover study (reversed order)",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Comparator 1","Dapagliflozin 10mg + Linagliptin 5mg",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Comparator 2","Metformin 1000mg",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Test Drug","Fixed-dose combination tablet (AJU-A53)",[9,17],[36],{"facility":37,"status":26,"city":38,"state":39,"zip":26,"country":40,"countryCode":26,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"Chung-Ang University Gwangmyeong Hospital","Gwangmyeong","Gyeonggi-do","South Korea",{"type":42,"coordinates":43},"Point",[44,45],126.86639,37.47722,{"lat":45,"lon":44},{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100596385","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-dapagliflozin-linagliptin-and-metformin-in-healthy-adults-fed-state-study-100596385",false,"NCT07044765","A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study","An Open-label, 2-arm, Single-sequence, Fed, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects","Inclusion Criteria:\n\n* Healthy adult volunteers aged 19 to 50 years at the time of screening.\n* Body mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\n  * Male subjects must weigh ≥50 kg.\n  * Female subjects must weigh ≥45 kg.\n* No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.\n* Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.\n* Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 7 days after the last dose, and agrees not to donate sperm or eggs during this period.\n* Able and willing to provide written informed consent after receiving a full explanation of the study.\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* History of excessive alcohol consumption within 1 month prior to the first dose:\n\n  * \\>21 drinks\u002Fweek for males, \\>14 drinks\u002Fweek for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)\n* Known hypersensitivity to any component of the investigational product.\n* Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:\n\n  * Moderate to severe renal impairment (eGFR or creatinine clearance \\\u003C45 mL\u002Fmin)\n  * Dialysis\n  * Acute or unstable heart failure\n  * Acute myocardial infarction, septicemia, or shock\n  * Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis\n  * Major surgery planned during the study (except minor procedures not affecting food or fluid intake)\n  * Severe infections, trauma, or nutritional deficiencies\n* Positive pregnancy test or currently breastfeeding (for female subjects).\n* History of significant psychiatric illness.\n* Determined by the investigator to be unsuitable for the study for any other reason.",true,"ALL","19 Years","50 Years",{"count":61,"type":62},32,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).",[68],"Type2 Diabetes Mellitus","NOT_YET_RECRUITING","2025-06-26",{"date":72,"type":73},"2025-07-01","ACTUAL",{"date":75,"type":62},"2025-08",{"date":77,"type":62},"2025-11",{"name":5,"class":6},1]