[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100282358":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":43,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":25,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":25,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Hanlim Pharm. Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"R-T","EXPERIMENTAL","First period: administration of reference drug, Second period: administration of test drug",[13,14],"Drug: Sevikar tab. 10\u002F40mg","Drug: Lodivikar tab. 5\u002F40mg",{"label":16,"type":10,"description":17,"interventionNames":18},"T-R","First period: administration of test drug, Second period: administration of reference drug",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sevikar tab. 10\u002F40mg","Reference drug: Sevikar tab. 10\u002F40mg, 1T, single oral administration in the fasted state",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Lodivikar tab. 5\u002F40mg","Test drug: Lodivikar tab 5\u002F40mg, 1T, single oral administration in the fasted state",[9,16],[31],{"facility":32,"status":25,"city":33,"state":34,"zip":35,"country":36,"countryCode":25,"cosmosGeoPoint":37,"geoPoint":42,"contacts":25},"Metrohospital","Anyang","Kyung Gi","430-720","South Korea",{"type":38,"coordinates":39},"Point",[40,41],127.49001,35.62128,{"lat":41,"lon":40},{"type":44,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100282358","phase-1-clinical-trial-to-assess-the-pharmacokinetic-characteristics-of-lodivikar-tab-540-mg-in-healthy-adult-male-subjects-100282358",false,"NCT02955498","Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5\u002F40 mg in Healthy Adult Male Subjects","A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5\u002F40 mg in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Healthy male in the age of 20-45\n* Body weight ≥ 55kg, IBW ± 20%\n* Subject who sign on an informed consent form willingly\n\nExclusion Criteria:\n\n* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease\n* Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives\n* Clinically significant hypotension (SBP≤100mmHg, DBP≤60mmHg) or hypertension(SBP≥150mmHg, DBP≥95mmHg) when screening period\n* Subject with known for history of disease or gastric surgery which affect on the absorption,\n* Subject with any of the following conditions in laboratory test\n\n  * AST or ALT \\> UNL (upper normal limit) x 1.5\n  * Total bilirubin \\> UNL x 1.5\n  * Renal failure with CLcr \\\u003C 50mL\u002Fmin calculated on Cockcroft-Gault \\[Cockcroft-Gault GFR = (140-age) \\* (Wt in kg) \u002F (72 \\*Cr)\\]\n  * Serum potassium \\\u003C 3.5 mEq\u002FL or \\> 5.5 mEq\u002FL\n* Continued excessive use of caffeine (caffeine \\>five cups\u002Fday), alcohol(alcohol\\>30g\u002Fday) and severe heavy smoker(cigarette \\>10 cigarettes per day)\n* Participation in any clinical investigation within 60days prior to study medication dosing\n* Subject with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing\n* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing\n* Use of any prescription medication including oriental medication within 14 days prior to study medication dosing or over-the-counter medication within 7 days prior to study medication dosing\n* Subject with mental illness or drug addiction\n* Subject taking foods which affect on the absorption, distribution, metabolism or excretion of drug within 7days prior to study medication dosing\n* Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator",true,"MALE","20 Years","45 Years",{"count":57,"type":58},32,"ACTUAL","INTERVENTIONAL",[61],"PHASE1","The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10\u002F40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5\u002F40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.",[64],"Healthy Male Subjects","COMPLETED","2016-11-02",{"date":68,"type":69},"2016-11-04","ESTIMATED",{"date":71,"type":25},"2014-04",{"date":73,"type":58},"2014-05",{"name":5,"class":6},1]