[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100156217":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":48,"centralContacts":52,"locations":53,"responsibleParty":67,"collaborators":52,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":52,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":52,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":52,"overallStatus":89,"whyStopped":52,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A-Saxagliptin+Metformin XR","EXPERIMENTAL","5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fasted state.",[13,14],"Drug: Saxagliptin","Drug: Metformin XR",{"label":16,"type":10,"description":17,"interventionNames":18},"Treatment B-Saxagliptin\u002FMetformin XR FDC","5mg Saxagliptin \u002F 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fasted state.",[19],"Drug: Saxagliptin\u002FMetformin XR FDC",{"label":21,"type":10,"description":22,"interventionNames":23},"Treatment C-Saxagliptin+Metformin XR","5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fed state.",[13,14],{"label":25,"type":10,"description":26,"interventionNames":27},"Treatment D-Saxagliptin\u002FMetformin XR FDC","5mg Saxagliptin \u002F 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fed state.",[19],[29,36,42],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Saxagliptin","Tablet, Oral, 5 mg, once on Day 1 only",[9,21],[35],"Onglyza",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Metformin XR","Tablet, Oral, 500 mg, once on Day 1 only",[9,21],[41],"Glifage XR",{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Saxagliptin\u002FMetformin XR FDC","Tablet, Oral, 5\u002F500 mg, once on Day 1 only",[16,25],[47],"Onglyza\u002FGlucophage",[49],{"name":50,"affiliation":50,"role":51},"Bristol-Myers Squibb","STUDY_DIRECTOR",null,[54],{"facility":55,"status":52,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":52},"Local Institution","Campinas","São Paulo","13073","Brazil","BR",{"type":62,"coordinates":63},"Point",[64,65],-47.06083,-22.90556,{"lat":65,"lon":64},{"type":52,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":68,"oldOrganization":50},"Study Director","100156217","phase-1-be-study-of-the-fixed-dose-combination-of-5-mg-saxagliptin-and-500-mg-metformin-hcl-xr-tablet-relative-to-a-5-mg-saxagliptin-onglyza-tablet-and-a-500-mg-metformin-hcl-xr-glifage-xr-marketed-in-brazil-by-merck-sa-tablet-co-administered-to-healthy-subjects-in-the-fasted-and-fed-states-100156217",false,"NCT01305551","BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States","Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin Hydrochloride (HCl) XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States","Inclusion Criteria:\n\n* Healthy men and women\n* Women of childbearing potential (WOCBP) who are using acceptable method of contraception\n* Women who are not nursing\n\nExclusion Criteria:\n\n* History of Gastrointestinal (GI) disease\n* Any GI surgery that could impact study drug absorption\n* History of allergy to drug class or related compounds\n* History of allergy to metformin or other similar acting agents.\n* History of any significant drug allergy.\n* Estimated creatinine clearance (ClCr) \\\u003C 80 mL\u002Fmin using Cockcroft-Gault formula",true,"ALL","18 Years","55 Years",{"count":81,"type":82},0,"ACTUAL","INTERVENTIONAL",[85],"PHASE1","The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin\u002F500 mg Metformin extended release (XR) fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.",[88],"Type 2 Diabetes","WITHDRAWN","2014-06-04",{"date":92,"type":93},"2014-06-05","ESTIMATED",{"date":95,"type":52},"2011-03",{"date":95,"type":82},{"name":5,"class":6},1]