[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100168218":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},"Janssen Research & Development, LLC","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 = 300, 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 = 150\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 = 150\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 = 300, 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},"Janssen Research & Development, LLC L.LC. 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},"Lincoln","Nebraska","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-96.66696,40.8,{"lat":42,"lon":41},{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":45,"oldOrganization":5},"DIRECTOR, CLIN PHARM LEADER","100168218","phase-1-a-study-to-assess-the-bioequivalence-of-fixed-dose-combination-fdc-tablets-of-canagliflozin-and-metformin-immediate-release-ir-with-respect-to-the-individual-components-of-canagliflozin-and-metformin-ir-tablets-in-healthy-volunteers-100168218",false,"NCT01463228","A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers","A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of FDC Tablets of Canagliflozin and Metformin IR (2x150 mg\u002F1000 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR (2x1000 mg) Tablets 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","19 Years","55 Years",{"count":58,"type":59},83,"ACTUAL","INTERVENTIONAL",[62],"PHASE1","The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet 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","2012-08-21",{"date":74,"type":75},"2012-08-22","ESTIMATED",{"date":77,"type":11},"2011-09",{"date":79,"type":59},"2012-01",{"name":5,"class":6},1]