[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100147558":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":11,"locations":45,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"5 mg saxagliptin + 2 Glucophage XR 500 mg tablet","EXPERIMENTAL",null,[13,14],"Drug: saxagliptin","Drug: Glucophage XR",{"label":16,"type":10,"description":17,"interventionNames":18},"FDC tablet (5 mg saxa + 1000 mg metformin XR) (single dose)","under fed state, single dose",[19],"Drug: saxagliptin + metformin XR (FDC tablet)",{"label":21,"type":10,"description":22,"interventionNames":23},"FDC tablet (5 mg saxa + 1000 mg metformin XR) (4 days)","under fed state, 4 days",[19],[25,32,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","saxagliptin","Tablets, Oral, 5 mg, once daily, Single dose",[9],[31],"Onglyza",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Glucophage XR","Tablets, Oral, 500 mg, once daily, Single dose",[9],{"type":26,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"saxagliptin + metformin XR (FDC tablet)","Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days",[21,16],[31],[42],{"name":43,"affiliation":43,"role":44},"Bristol-Myers Squibb","STUDY_DIRECTOR",[46],{"facility":47,"status":11,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":11},"PPD Development, LP","Austin","Texas","78744","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-97.74306,30.26715,{"lat":57,"lon":56},{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100147558","phase-1-bioequivalence-study-of-the-fixed-dose-combination-of-5-mg-saxagliptin1000-mg-metformin-xr-manufactured-in-mt-vernon-in-relative-to-5-mg-of-onglyza-and-2--500-mg-glucophage-xr-100147558",true,"NCT01192152","Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin\u002F1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR","Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin\u002F1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR Coadministered to Healthy Subjects in the Fed State and Steady State Pharmacokinetic Assessment of the Fixed Dose Combination of 5 mg Saxagliptin\u002F1000 mg Metformin XR","Inclusion Criteria:\n\n* Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n* Body Mass Index (BMI) of 18 to 32 kg\u002Fm², inclusive\n* Ages 18 to 55, inclusive\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population\n* Major surgical procedure within 4 weeks prior to randomization\n* Positive serology test for HIV, HBV or HCV\n* Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease\n* History of gastrointestinal disease within the past 3 months\n* Any clinically significant medical condition that could potentially affect your participation in the study and\u002For personal well-being, as judged by the investigator\n* Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization\n* Unable to tolerate oral and\u002For intravenous (IV) medications\n* Unable to tolerate the puncturing of veins for drawing of blood\n* Known allergy or hypersensitivity to any component of the study medication\n* History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)\n* Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization\n* Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization\n* Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization","ALL","18 Years","45 Years",{"count":72,"type":73},30,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin\u002F1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.",[79],"Diabetes Mellitus","COMPLETED","2015-04-22",{"date":83,"type":84},"2015-05-12","ESTIMATED",{"date":86,"type":11},"2009-11",{"date":88,"type":73},"2009-12",{"name":5,"class":6},1]