[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316775":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":27,"responsibleParty":39,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group","EXPERIMENTAL","Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule)",[13],"Drug: Vancomycin 250Mg Capsule",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Vancomycin 250Mg Capsule","Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.",[9],[21],"simvastatin",[23],{"name":24,"affiliation":5,"role":25},"SeungHwan Lee, MD, PhD","PRINCIPAL_INVESTIGATOR",null,[28],{"facility":29,"status":26,"city":30,"state":26,"zip":31,"country":32,"countryCode":26,"cosmosGeoPoint":33,"geoPoint":38,"contacts":26},"Seoul National University Hospital Clinical Trial Center","Seoul","03080","South Korea",{"type":34,"coordinates":35},"Point",[36,37],126.9784,37.566,{"lat":37,"lon":36},{"type":25,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SeungHwan Lee","Clinical Assistant Professor","100316775","phase-1-evaluate-the-effects-of-the-environmental-change-in-intestine-by-antibiotics-on-the-pharmacokinetic-characteristics-of-simvastatin-in-healthy-male-volunteers-100316775",false,"NCT03403972","Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers","A Clinical Trial to Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers","Inclusion Criteria:\n\n* Age between 19 Y to 50 Y at the screening\n* Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg\u002Fm2\n* Informed consent will be taken before all the procedures from volunteers\n* SLCO1B1 genotype is \\*1\u002F\\*1 when screening\n\nExclusion Criteria:\n\n* No significant disease history or ongoing disease\n* Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin\n* MDRD eGFR less than 60 mL\u002Fmin\u002F1.73m2\n* Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening\n* HDL less than 35 mg\u002FdL at the screening\n* Positive HBV or HIV or HCV\n* Who is administering or going to administer CYP3A4 inihibitor drug\n* Other clinically significant situation under doctor's opinion",true,"MALE","19 Years","50 Years",{"count":54,"type":55},6,"ACTUAL","INTERVENTIONAL",[58],"PHASE1","This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.",[61],"Simvastatin Pharmacokinetics and Gut Microbiome",[63,21,64,65],"pharmacokinetics","vancomycin","gut microbiome","COMPLETED","2018-01-18",{"date":69,"type":55},"2018-01-19",{"date":71,"type":55},"2017-12-06",{"date":73,"type":55},"2018-01-11",{"name":5,"class":6},1]