[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356405":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":55,"centralContacts":60,"locations":66,"responsibleParty":81,"collaborators":64,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":64,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":64,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":110,"whyStopped":64,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",[8,16,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1","EXPERIMENTAL","Period 1: CKD-386 formulation 1(1 tab, once) \u002F Period 2: CKD-386 formulation 2(1 tab, once) \u002F Period 3: D326, D337, D013(3 tabs, once)",[13,14,15],"Drug: CKD-386 formulation 1","Drug: CKD-386 formulation 2","Drug: D326, D337 and D013",{"label":17,"type":10,"description":18,"interventionNames":19},"Sequence 2","Period 1: CKD-386 formulation 1(1 tab, once) \u002F Period 2: D326, D337, D013(3 tabs, once) \u002F Period 3: CKD-386 formulation 2(1 tab, once)",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Sequence 3","Period 1: CKD-386 formulation 2(1 tab, once) \u002F Period 2: D326, D337, D013(3 tabs, once) \u002F Period 3: CKD-386 formulation 1(1 tab, once)",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Sequence 4","Period 1: CKD-386 formulation 2(1 tab, once) \u002F Period 2: CKD-386 formulation 1(1 tab, once) \u002F Period 3: D326, D337, D013",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"Sequence 5","Period 1: D326, D337, D013(3 tabs, once) \u002F Period 2: CKD-386 formulation 1(1 tab, once) \u002F Period 3: CKD-386 formulation 2(1 tab, once)",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Sequence 6","Period 1: D326, D337, D013 (3 tabs, once)\u002F Period 2: CKD-386 formulation 2(1 tab, once) \u002F Period 3: CKD-386 formulation 1(1 tab, once)",[13,14,15],[37,44,49],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","CKD-386 formulation 1","A single oral dose of 1 tablet under fasting conditions for each period",[9,17,21,25,29,33],[43],"CKD-386 Test 1",{"type":38,"name":45,"description":40,"armGroupLabels":46,"otherNames":47},"CKD-386 formulation 2",[9,17,21,25,29,33],[48],"CKD-386 Test 2",{"type":38,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"D326, D337 and D013","A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period",[9,17,21,25,29,33],[54],"CKD-386 Reference",[56],{"name":57,"affiliation":58,"role":59},"Dongseong Shin, M.D, Ph.D","Clinical Trials Center, Gil Medical Center, Incheon, Korea","PRINCIPAL_INVESTIGATOR",[61],{"name":57,"role":62,"phone":63,"phoneExt":64,"email":65},"CONTACT","+82-32-460-9459",null,"dsshin@gilhospital.com",[67],{"facility":68,"status":69,"city":70,"state":64,"zip":71,"country":72,"countryCode":64,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Gachon University Gil Medical Center","RECRUITING","Incheon","21565","South Korea",{"type":74,"coordinates":75},"Point",[76,77],126.70515,37.45646,{"lat":77,"lon":76},[80],{"name":57,"role":62,"phone":63,"phoneExt":64,"email":65},{"type":82,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100356405","phase-1-a-clinical-trial-to-investigate-the-pharmacokinetics-and-safetytolerability-of-ckd-386-in-healthy-male-volunteers-100356405",false,"NCT03920579","A Clinical Trial to Investigate the Pharmacokinetics and Safety\u002FTolerability of CKD-386 in Healthy Male Volunteers","A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety\u002FTolerability According to Formulations of CKD-386 in Healthy Male Volunteers","Inclusion Criteria:\n\n1. Healthy volunteers aged between ≥20 and ≤45 years old\n2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg\u002Fm2\n3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings\n4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests\n5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial\n\nExclusion Criteria:\n\n1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug\n2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption\n3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests",true,"MALE","19 Years","45 Years",{"count":95,"type":96},30,"ESTIMATED","INTERVENTIONAL",[99],"PHASE1","a study to investigate the pharmacokinetic characteristics and safety\u002Ftolerability according to formulations of CKD-386 in healthy male volunteers",[102,103],"Hypertension","Dyslipidemias",[105,106,107,108,109],"CKD-386","Pharmacokinetics","D326","D337","D013","UNKNOWN","2019-04-17",{"date":113,"type":114},"2019-04-19","ACTUAL",{"date":116,"type":114},"2019-04-01",{"date":118,"type":96},"2019-05",{"name":5,"class":6},1]