[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100147557":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":11,"locations":46,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":81,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"5 mg saxagliptin + a single 500 mg metformin XR tablet","EXPERIMENTAL",null,[13,14],"Drug: saxagliptin","Drug: metformin XR",{"label":16,"type":10,"description":17,"interventionNames":18},"FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fed)","under fed state",[19],"Drug: saxagliptin + metformin XR (FDC tablet)",{"label":21,"type":10,"description":22,"interventionNames":23},"FDC tablet (5 mg saxagliptin + 500 mg metformin XR) (Fasting)","under fasted state",[19],[25,32,38],{"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":36},"metformin XR","Tablets, Oral, 500 mg. once daily, Single dose",[9],[37],"Glucophage XR",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"saxagliptin + metformin XR (FDC tablet)","Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose",[21,16],[43],{"name":44,"affiliation":44,"role":45},"Bristol-Myers Squibb","STUDY_DIRECTOR",[47],{"facility":48,"status":11,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":11},"Ppd Development, Lp","Austin","Texas","78744","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-97.74306,30.26715,{"lat":58,"lon":57},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100147557","phase-1-bioequivalence-study-of-the-fixed-dose-combination-of-5-mg-saxagliptin-and-500-mg-metformin-xr-tablet-manufactured-in-mt-vernon-in-relative-to-5-mg-saxagliptin-tablet-and-500-mg-metformin-xr-tablet-manufactured-in-evansville-in-100147557",true,"NCT01192139","Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)","Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN) Coadministered to Healthy Subjects in a Fed Condition","Inclusion Criteria:\n\n* Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations\n* Body Mass Index (BMI) of 18 to 32 kg\u002Fm2, inclusive\n* Ages 18 to 45, 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (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":73,"type":74},30,"ACTUAL","INTERVENTIONAL",[77],"PHASE1","The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin\u002F500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana \\[IN\\]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects.",[80],"Diabetes Mellitus","COMPLETED","2015-05-04",{"date":84,"type":85},"2015-05-21","ESTIMATED",{"date":87,"type":11},"2009-11",{"date":89,"type":74},"2009-12",{"name":5,"class":6},1]