[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205660":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":39,"centralContacts":11,"locations":44,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"1 combination tablet EC905","EXPERIMENTAL",null,[13],"Drug: EC905",{"label":15,"type":10,"description":11,"interventionNames":16},"2: solifenacin",[17],"Drug: solifenacin",{"label":19,"type":10,"description":11,"interventionNames":20},"3: tamsulosin",[21],"Drug: tamsulosin",[23,28,34],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","EC905","Oral",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"solifenacin","oral",[15],[33],"Vesicare®",{"type":24,"name":35,"description":30,"armGroupLabels":36,"otherNames":37},"tamsulosin",[19],[38],"Omnic OCAS®",[40],{"name":41,"affiliation":42,"role":43},"Study Manager","Astellas Pharma Europe B.V.","STUDY_CHAIR",[45],{"facility":46,"status":11,"city":47,"state":11,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":11},"Parexel","London","HA1 3UJ","United Kingdom","UK",{"type":52,"coordinates":53},"Point",[54,55],-0.12574,51.50853,{"lat":55,"lon":54},{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100205660","phase-1-a-study-to-compare-the-amount-of-drug-in-the-blood-after-a-single-tablet-ec905-containing-solifenacin-and-tamsulosin-is-taken-by-healthy-males-compared-to-separate-tablets-of-solifenacin-and-tamsulosin-100205660",false,"NCT01953887","A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin","An Open-label, Randomized, Three-period Crossover, Single Dose Study to Compare the Pharmacokinetics of the Final EC905 Formulation to Marketed Solifenacin (Vesicare®) and Tamsulosin OCAS (Omnic OCAS®)","Inclusion Criteria:\n\n* Body Mass Index between 18.5 and 30.0 kg\u002Fm2, inclusive\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to solifenacin, tamsulosin, EC905, Vesicare, Omnic OCAS or any of the components of the formulations used.\n* Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin.\n* Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject.\n* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2",true,"MALE","18 Years","55 Years",{"count":71,"type":72},30,"ACTUAL","INTERVENTIONAL",[75],"PHASE1","A study to assess the amount of drug in the blood of young to middle aged, healthy, male subjects after they received the final formulation of EC905 compared to solifenacin (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).\n\nSubjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS® in 3 separate periods.",[25,78,79],"Pharmacokinetics","Healthy Subjects",[81,82,83,84,85],"Phase I","Final formulation EC905","Solifenacin succinate","Tamsulosin HCl","Marketed drugs","COMPLETED","2014-05-28",{"date":89,"type":90},"2014-05-29","ESTIMATED",{"date":92,"type":11},"2010-03",{"date":94,"type":72},"2010-07",{"name":42,"class":6},1]