[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553943":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":22,"studyPopulation":15,"armGroups":23,"interventions":35,"overallOfficials":48,"centralContacts":53,"locations":15,"responsibleParty":59,"collaborators":15,"id":61,"slug":15,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":15,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":15,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":15,"overallStatus":80,"whyStopped":15,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":15},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg\u002Fm2 and less than 30 kg\u002Fm2)","Pharmacokinetic characterization","0 hour ~ 48 hour after drug administration",{"measure":14,"description":11,"timeFrame":12},"Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg\u002Fm2 and less than 30 kg\u002Fm2)",null,{"allocation":17,"interventionModel":18,"interventionModelDescription":15,"primaryPurpose":19,"observationalModel":15,"timePerspective":15,"maskingInfo":20},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":21,"maskingDescription":15,"whoMasked":15},"NONE","Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)",[24,31],{"label":25,"type":26,"description":27,"interventionNames":28},"Group 1","OTHER","* Period 1: CKD-383 two tablets(Fed)\n* Period 2: CKD-383 two tablets(Fasted)",[29,30],"Drug: CKD-383(Fed)","Drug: CKD-383(Fasted)",{"label":32,"type":26,"description":33,"interventionNames":34},"Group 2","* Period 1: CKD-383 two tablets(Fasted)\n* Period 2: CKD-383 two tablets(Fed)",[29,30],[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","CKD-383(Fed)","After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.",[25,32],[42],"Lobeglitazone, Empagliflozin, Metformin",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"CKD-383(Fasted)","After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.",[25,32],[42],[49],{"name":50,"affiliation":51,"role":52},"Jaeyong chung, PI","Seoul National University Bundang Hospital","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":15,"email":58},"Jisoo Kim, PL","CONTACT","02-6373-0785","jisoo.kim@ckdpharm.com",{"type":60,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100553943",false,"NCT06492655","To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers","A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy adults aged 19 to 54 years\n* BMI measurement result is 18.0 kg\u002Fm2 to 30 kg\u002Fm2\n* Written informed consent\n* Other inclusion criteria, as defined in the protocol\n\nExclusion Criteria:\n\n* who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period\n\n  1 administration)\n* Other exclusive criteria, as defined in the protocol",true,"ALL","19 Years","54 Years",{"count":72,"type":73},28,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers",[79],"Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2024-07-09",{"date":83,"type":84},"2024-07-10","ACTUAL",{"date":86,"type":73},"2024-07-04",{"date":88,"type":73},"2024-08-08",{"name":5,"class":6}]