[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100167562":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":11,"locations":32,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Sequence AB","EXPERIMENTAL",null,[13],"Drug: A (canagliflozin and metformin IR individual tablets) \u002F B (canagliflozin\u002Fmetformin IR FDC tablets)",{"label":15,"type":10,"description":11,"interventionNames":16},"Treatment Sequence BA",[17],"Drug: B (canagliflozin\u002Fmetformin IR FDC tablets \u002F A (canagliflozin and metformin IR individual tablets)",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","A (canagliflozin and metformin IR individual tablets) \u002F B (canagliflozin\u002Fmetformin IR FDC tablets)","Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin\u002Fmetformin IR FDC): Type = 2, unit = mg, number = 50\u002F1000, form = tablet, route = oral use. Two canagliflozin\u002Fmetformin IR FDC tablets taken orally on Day 1 of Treatment Period 2",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"B (canagliflozin\u002Fmetformin IR FDC tablets \u002F A (canagliflozin and metformin IR individual tablets)","Treatment B (canagliflozin\u002Fmetformin IR FDC): Type = 2, unit = mg, number = 50\u002F1000, form = tablet, route = oral use. Two Canagliflozin\u002Fmetformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.",[15],[29],{"name":30,"affiliation":5,"role":31},"Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial","STUDY_DIRECTOR",[33],{"facility":11,"status":11,"city":34,"state":35,"zip":11,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":11},"Tempe","Arizona","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-111.90931,33.41477,{"lat":42,"lon":41},{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100167562","phase-1-a-study-to-assess-the-bioequivalence-of-2-fixed-dose-combination-fdc-tablets-of-canagliflozin-and-metformin-immediate-release-ir-50-mg1000-mg-with-respect-to-the-individual-components-of-canagliflozin-1-x-100-mg-and-metformin-ir-tablets-2-x-1000-mg-in-healthy-volunteers-100167562",false,"NCT01454622","A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg\u002F1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Volunteers","A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg\u002F1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects","Inclusion Criteria:\n\n\\- Body mass index (BMI) between 18.5 and 30 kg\u002Fm² (inclusive) and a body weight of not less than 50 kg\n\nExclusion Criteria:\n\n* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator",true,"ALL","18 Years","55 Years",{"count":58,"type":59},64,"ACTUAL","INTERVENTIONAL",[62],"PHASE1","The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.",[65],"Healthy",[67,68,69,70],"Healthy Volunteers","Bioequivalence","Canagliflozin (JNJ-28431754)","Metformin IR","COMPLETED","2013-05-03",{"date":74,"type":75},"2013-05-06","ESTIMATED",{"date":77,"type":11},"2011-09",{"date":79,"type":59},"2011-11",{"name":5,"class":6},1]