[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100279643":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":29,"locations":29,"responsibleParty":39,"collaborators":29,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":29,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":29,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":29,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":29},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence A","EXPERIMENTAL","Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)\n\nThere will be a washout of 14 days between the each period.",[13,14],"Drug: Fimasartan\u002FAmlodipine","Drug: Fimasartan + Amlodipine",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence B","Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)\n\nThere will be a washout of 14 days between the each period.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Sequency C","Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)\n\nThere will be a washout of 14 days between the each period.",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Fimasartan\u002FAmlodipine","Treatment B",[9,16,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Fimasartan + Amlodipine","Treatment A",[9,16,20],[35],{"name":36,"affiliation":37,"role":38},"Kyung-Sang Yu, PhD","Seoul National University Hospital","PRINCIPAL_INVESTIGATOR",{"type":40,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100279643","phase-1-a-clinical-trial-to-evaluate-the-pharmacokinetics-and-safety-of-fimasartan-and-amlodipine-in-healthy-male-subjects-100279643",false,"NCT02920047","A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects","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\u002FAmlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers","Inclusion Criteria:\n\n1. Male 19-50 years of age.\n2. Body mass index (BMI) ≥ 18 and ≤ 27 kg\u002Fm2 at screening.\n3. Medically healthy with no clinically significant medical history.\n4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n1. History or presence of clinically significant medical or psychiatric condition or disease.\n2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n3. Seated blood pressure is less than 100\u002F65 mmHg or greater than 140\u002F90 mmHg at screening.\n4. Plasma donation within a month prior to the first dose of study drug.\n5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).",true,"MALE","19 Years","50 Years",{"count":53,"type":54},60,"ACTUAL","INTERVENTIONAL",[57],"PHASE1","The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan\u002FAmlodipine and when co-administrated Fimasartan and Amlodipine.",[60],"Hypertension",[62],"Fimasartan","COMPLETED","2018-01-07",{"date":66,"type":54},"2018-01-09",{"date":68,"type":54},"2016-10",{"date":70,"type":54},"2017-01",{"name":5,"class":6}]