[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100128265":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":27,"acronym":11,"eligibilityCriteria":28,"healthyVolunteers":29,"sex":30,"minAge":31,"maxAge":32,"enrollmentInfo":33,"targetDuration":11,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":42,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":54,"locationsCount":11},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fimasartan","EXPERIMENTAL",null,[13],"Drug: fimasartan, warfarin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","fimasartan, warfarin","Warfarin(1d) Fimasartan(8d-16d) Fimasartan + Warfarin(11d)",[9],{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":21,"oldOrganization":22},"Choi, Director","Boryung Pharm Co., Inc.","100128265","phase-1-a-clinical-trial-to-evaluate-the-effect-of-fimarsartan-on-pharmacodynamics-pharmacokinetics-and-the-safety-of-warfarin-in-healthy-male-volunteers-100128265",false,"NCT00938132","A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin in Healthy Male Volunteers","Inclusion Criteria:\n\n* age: 20 - 40 years\n* sex: male\n* body weight: greater than 55 kg\n* written informed consent\n\nExclusion Criteria:\n\n* known allergy to Fimasartan and warfarin\n* existing cardiac or hematological diseases\n* existing hepatic and renal diseases\n* existing gastrointestinal diseases\n* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder\n* positive drug or alcohol screening\n* smokers of 10 or more cigarettes per day 3 month ago\n* participation in a clinical trial during the last 2 months prior to the start of the study",true,"MALE","20 Years","40 Years",{"count":34,"type":35},15,"ESTIMATED","INTERVENTIONAL",[38],"PHASE1","To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.",[41],"Essential Hypertension",[43,44],"fimasartan","drug interaction","COMPLETED","2009-10-07",{"date":48,"type":35},"2009-10-08",{"date":50,"type":11},"2009-07",{"date":52,"type":53},"2009-09","ACTUAL",{"name":5,"class":6}]