[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224889":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":24,"locations":37,"responsibleParty":48,"collaborators":50,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":24,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":73,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Boryung Pharmaceutical Co., Ltd","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment AB","OTHER","Treatment A (1 day) → wash-out(7days) → Treatment B (1 day)\n\nTreatment A : Fimasartan and Rosuvastatin\n\nTreatment B : Fimasartan\u002FRosuvastatin combination",[13,14,15],"Drug: Fimasartan","Drug: Rosuvastatin","Drug: Fimasartan\u002FRosuvastatin combination",{"label":17,"type":10,"description":18,"interventionNames":19},"Treatment BA","Treatment B (1 day) → wash-out(7days) → Treatment A (1 day)\n\nTreatment A : Fimasartan and Rosuvastatin\n\nTreatment B : Fimasartan\u002FRosuvastatin combination",[13,14,15],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":24},"DRUG","Fimasartan",null,[9,17],{"type":22,"name":27,"description":24,"armGroupLabels":28,"otherNames":24},"Rosuvastatin",[9,17],{"type":22,"name":30,"description":24,"armGroupLabels":31,"otherNames":24},"Fimasartan\u002FRosuvastatin combination",[9,17],[33],{"name":34,"affiliation":35,"role":36},"youngran yoon, M.D., Ph.D.","Kyungpook National University Hospital","PRINCIPAL_INVESTIGATOR",[38],{"facility":35,"status":24,"city":39,"state":24,"zip":40,"country":41,"countryCode":24,"cosmosGeoPoint":42,"geoPoint":47,"contacts":24},"Daegu","700-721","South Korea",{"type":43,"coordinates":44},"Point",[45,46],128.59111,35.87028,{"lat":46,"lon":45},{"type":49,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[51],{"name":35,"class":10},"100224889","phase-1-to-compare-the-pharmacokinetics-and-safety-of-fimasartanrosuvastatin-combination-tablet-and-coadministration-of-fimasartan-and-rosuvastatin-100224889",false,"NCT02205190","to Compare the Pharmacokinetics and Safety of Fimasartan\u002FRosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin","A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan\u002FRosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers","Inclusion Criteria:\n\n1. Healthy male subject, aged 19- 55 years at screening.\n2. Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} \\* 0.9\n3. No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease that requires treatment\n4. Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) and ECG, performed within 3 weeks prior to administration of study drug\n5. Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent\n\nExclusion Criteria:\n\n1. History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.5).\n2. History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)\n3. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening\n4. Active liver disease, or the levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin \\> 1.5 x the upper limit of normal\n5. Creatinine clearance \\\u003C 60 mL\u002Fmin (calculated by Cockcroft-Gault formula using serum creatinine)\n6. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n7. History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)\n8. History of major injury, surgical operation, or suspected symptom of acute illness (severe infection, trauma, diarrhea or vomiting) within 4 weeks prior to the first administration of study drug\n9. History of excessive alcohol abuse (\\>21 units\u002Fweek, 1 unit=10g=12.5mL of pure alcohol), or subjects who cannot abstain from drinking for at least 3 days prior to the start of this study and throughout the study period, or excessive smoking (\\>10 cigarettes\u002Fday)\n10. Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator\n11. Participation in any other study within 3 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)\n12. Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood products within 1 month prior to the first administration of study drug\n13. Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs (\\*e.g., Grapefruit juice ≥ 1L \u002Fday within 7 days prior to administration of study drug)\n14. Positive serologic tests (HBsAg, HCV Ab, HIV Ag\u002FAb, VDRL)\n15. Subject that is judged inappropriate for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis) or any other reason",true,"MALE","19 Years","55 Years",{"count":64,"type":65},81,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan\u002Frosuvastatin combination tablet and coadministration of fimasartan and rosuvastatin in healthy male volunteers",[71],"Hypertension",[23],"COMPLETED","2014-10-13",{"date":76,"type":77},"2014-10-15","ESTIMATED",{"date":79,"type":24},"2014-07",{"date":81,"type":65},"2014-09",{"name":5,"class":6},1]