[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285369":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":23,"locations":25,"responsibleParty":36,"collaborators":23,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":23,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":23,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":23,"overallStatus":58,"whyStopped":23,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A fixed dose combination group","EXPERIMENTAL","A fixed dose combination of Fimasartan\u002FAtorvastatin",[13],"Drug: Fimasartan, Atorvastatin",{"label":15,"type":16,"description":17,"interventionNames":18},"Co-administration group","ACTIVE_COMPARATOR","Co-administration of Fimasartan and Atorvastatin",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":23},"DRUG","Fimasartan, Atorvastatin",null,[9,15],[26],{"facility":27,"status":23,"city":28,"state":23,"zip":23,"country":29,"countryCode":23,"cosmosGeoPoint":30,"geoPoint":35,"contacts":23},"Seoul National University Hospital","Seoul","South Korea",{"type":31,"coordinates":32},"Point",[33,34],126.9784,37.566,{"lat":34,"lon":33},{"type":37,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100285369","phase-1-a-clinical-trial-to-evaluate-the-pharmacokinetics-and-safetytolerability-of-fimasartan-and-atorvastatin-in-healthy-male-volunteers-100285369",false,"NCT02994745","A Clinical Trial to Evaluate the Pharmacokinetics and Safety\u002FTolerability of Fimasartan and Atorvastatin in Healthy Male Volunteers.","A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety\u002FTolerability Between a Fixed Dose Combination of Fimasartan 120mg\u002FAtorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.","Inclusion Criteria:\n\n* A Healthy male aged 19-50 years\n* Body weight is over 55kg and BMI 18 \\~ 27(kg\u002Fm2).\n* A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.\n* A subject who is eligible according to investigator's assessment\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical or psychiatric condition or disease.\n* History of gastrointestinal disease and resection\n* Hypersensitivity to ingredient of investigational product(IP) and other medication, food.\n* Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.\n* A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.\n* Positive results for serum examination(HIV, B and C viral test, Syphilis).\n* Seated BP is less than 100\u002F65 mmHg or greater than 140\u002F90 mmHg at screening.\n* Participation in any other study within 3months.\n* History of whole blood donation within 2months and Apheresis 2 weeks.",true,"MALE","19 Years","50 Years",{"count":50,"type":51},60,"ACTUAL","INTERVENTIONAL",[54],"PHASE1","The purpose of this study is to evaluate the Pharmacokinetics and Safety \u002F Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.",[57],"Hypertension, Hyperlipidemia","COMPLETED","2018-01-16",{"date":61,"type":51},"2018-01-18",{"date":63,"type":51},"2016-12-23",{"date":65,"type":51},"2017-08",{"name":5,"class":6},1]