[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100195730":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":21,"locations":26,"responsibleParty":37,"collaborators":21,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":21,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":21,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":21,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Severance Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Test and reference formulations","EXPERIMENTAL","Test formulation and reference formulation given orally 7 days apart in a fasted state",[13,14],"Drug: Test formulation","Drug: Reference formulation",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Test formulation","Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Reference formulation","Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet",[9],[27],{"facility":5,"status":21,"city":28,"state":21,"zip":29,"country":30,"countryCode":21,"cosmosGeoPoint":31,"geoPoint":36,"contacts":21},"Seoul","120-752","South Korea",{"type":32,"coordinates":33},"Point",[34,35],126.9784,37.566,{"lat":35,"lon":34},{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Kyungsoo Park","Associate Professor","100195730","phase-1-safety-and-pharmacokinetic-comparison-of-co-administration-and-a-combination-drug-of-rosuvastatin-and-olmesartan-in-healthy-male-volunteers-100195730",false,"NCT01823900","Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers","A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers","Inclusion Criteria:\n\n* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease\n\nExclusion Criteria:\n\n* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;\n* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;\n* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;\n* Use of any substance that could induce or inhibit drug metabolism enzymes",true,"MALE","20 Years","50 Years",{"count":53,"type":54},58,"ACTUAL","INTERVENTIONAL",[57],"PHASE1","This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers",[60],"Healthy",[62],"Pharmacokinetics","COMPLETED","2013-04-09",{"date":66,"type":67},"2013-04-11","ESTIMATED",{"date":69,"type":21},"2012-01",{"date":71,"type":54},"2012-03",{"name":5,"class":6},1]