[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100237904":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":37,"locations":38,"responsibleParty":50,"collaborators":37,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":37,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":37,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":37,"overallStatus":72,"whyStopped":37,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Dong-A ST Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"DA-1229_01 → E+M","EXPERIMENTAL","DA-1229\\_01 : Evogliptin\u002FMetformin XR 2.5\u002F500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg",[13,14],"Drug: DA-1229_01","Drug: E+M",{"label":16,"type":10,"description":11,"interventionNames":17},"E+M → DA-1229_01",[13,14],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","DA-1229_01","complex single administration",[9,16],[25],"Evogliptin\u002FMetformin XR 2.5\u002F500 mg x 2 Tablets",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"E+M","co-administration of 2 drugs",[9,16],[31],"Evogliptin 5 mg + Metformin XR 1000 mg",[33],{"name":34,"affiliation":35,"role":36},"Kyung-sang Yu, Ph.D, M.B.A","Seoul National University Hospital","PRINCIPAL_INVESTIGATOR",null,[39],{"facility":40,"status":37,"city":41,"state":37,"zip":42,"country":43,"countryCode":37,"cosmosGeoPoint":44,"geoPoint":49,"contacts":37},"Clinical Trial Center, Seoul National University Hospital","Seoul","110-744","South Korea",{"type":45,"coordinates":46},"Point",[47,48],126.9784,37.566,{"lat":48,"lon":47},{"type":51,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100237904","phase-1-a-clinical-trial-to-investigate-safetytolerability-and-pharmacokinetics-of-da-122901evogliptinmetformin-xr-25500-mg-x-2-tablets-compared-to-co-administration-of-evogliptin-5-mg-and-metformin-xr-1000-mg-in-healthy-male-volunteers-100237904",false,"NCT02375139","A Clinical Trial to Investigate Safety\u002FTolerability and Pharmacokinetics of DA-1229_01(Evogliptin\u002FMetformin XR 2.5\u002F500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers","A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety\u002FTolerability and Pharmacokinetics of DA-1229_01 (Evogliptin\u002FMetformin XR 2.5\u002F500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg After Single Oral Administration in Healthy Male Volunteers","Inclusion Criteria:\n\n* Age between 19 to 45, healthy male subjects(at screening)\n* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0\n* FPG 60-125mg\u002FdL glucose level(at screening)\n* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.\n\nExclusion Criteria:\n\n* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)\n* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)\n* Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction\n* Subject who already participated in other trials in 2 months\n* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion",true,"MALE","19 Years","45 Years",{"count":64,"type":65},36,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","This Phase I clinical study is to evaluate the safety\u002Ftolerability and pharmacokinetics of DA-1229\\_01(Evogliptin\u002FMetformin XR 2.5\u002F500 mg x 2 tablets).",[71],"Type 2 Diabetes Mellitus","COMPLETED","2015-07-21",{"date":75,"type":76},"2015-07-22","ESTIMATED",{"date":78,"type":37},"2015-04",{"date":80,"type":65},"2015-06",{"name":5,"class":6},1]