[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100221968":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":48,"centralContacts":43,"locations":53,"responsibleParty":64,"collaborators":43,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":43,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":43,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":43,"overallStatus":86,"whyStopped":43,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Dong-A ST Co., Ltd.","INDUSTRY",[8,15,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"(Part 1) DA-1229_01 → E+M","EXPERIMENTAL","DA-1229\\_01 : Evogliptin\u002FMetformin XR 5\u002F1000mg 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},"(Part 1) E+M → DA-1229_01",[13,14],{"label":19,"type":10,"description":20,"interventionNames":21},"(Part 2) DA-1229_01 fast → fed","DA-1229\\_01 : Evogliptin\u002FMetformin XR 5\u002F1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet",[22,23],"Drug: DA-1229_01 fast","Drug: DA-1229_01 fed",{"label":25,"type":10,"description":20,"interventionNames":26},"DA-1229_01 fed → fast",[22,23],[28,35,41,45],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","DA-1229_01","complex single administration",[9,16],[34],"Evogliptin\u002FMetformin XR 5\u002F1000 mg",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"E+M","co-administration of 2 drugs",[9,16],[40],"Evogliptin 5 mg + Metformin XR 1000 mg",{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":43},"DA-1229_01 fast",null,[19,25],{"type":29,"name":46,"description":43,"armGroupLabels":47,"otherNames":43},"DA-1229_01 fed",[19,25],[49],{"name":50,"affiliation":51,"role":52},"Kyung-sang Yu, Ph.d., M.B.A","Seoul National University Hospital","PRINCIPAL_INVESTIGATOR",[54],{"facility":55,"status":43,"city":56,"state":43,"zip":43,"country":57,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":63,"contacts":43},"Clinical Trial Center, Seoul National University Hospital","Seoul","South Korea",{"type":59,"coordinates":60},"Point",[61,62],126.9784,37.566,{"lat":62,"lon":61},{"type":65,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100221968","phase-1-a-clinical-trial-to-investigate-safetytolerability-and-pharmacokinetics-of-da-122901-compared-to-co-administration-of-evogliptin-5-mg-and-metformin-xr-1000-mg-and-to-evaluate-the-effect-of-food-on-the-pharmacokinetics-of-da-122901-in-healthy-male-volunteers-100221968",false,"NCT02167061","A Clinical Trial to Investigate Safety\u002FTolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 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 5\u002F1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers","Inclusion Criteria:\n\n* Age between 20 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","20 Years","45 Years",{"count":78,"type":79},64,"ACTUAL","INTERVENTIONAL",[82],"PHASE1","This Phase I clinical study is to evaluate the safety\u002Ftolerability and pharmacokinetics of DA-1229\\_01 and to investigate the effect of food on the pharmacokinetics of DA-1229\\_01 in healthy male volunteers",[85],"Type 2 Diabetes Mellitus","COMPLETED","2014-11-27",{"date":89,"type":90},"2014-12-02","ESTIMATED",{"date":92,"type":43},"2014-07",{"date":94,"type":79},"2014-11",{"name":5,"class":6},1]