[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553943":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":44,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":42,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":42,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":42,"overallStatus":66,"whyStopped":42,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":42},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","OTHER","* Period 1: CKD-383 two tablets(Fed)\n* Period 2: CKD-383 two tablets(Fasted)",[13,14],"Drug: CKD-383(Fed)","Drug: CKD-383(Fasted)",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2","* Period 1: CKD-383 two tablets(Fasted)\n* Period 2: CKD-383 two tablets(Fed)",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9,16],[26],"Lobeglitazone, Empagliflozin, Metformin",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[9,16],[26],[33],{"name":34,"affiliation":35,"role":36},"Jaeyong chung, PI","Seoul National University Bundang Hospital","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Jisoo Kim, PL","CONTACT","02-6373-0785",null,"jisoo.kim@ckdpharm.com",{"type":45,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100553943","phase-1-to-evaluate-the-food-effect-on-pharmacokinetic-profiles-and-safety-in-healthy-volunteers-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":58,"type":59},28,"ESTIMATED","INTERVENTIONAL",[62],"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",[65],"Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2024-07-09",{"date":69,"type":70},"2024-07-10","ACTUAL",{"date":72,"type":59},"2024-07-04",{"date":74,"type":59},"2024-08-08",{"name":5,"class":6}]