[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100161188":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":25,"locations":36,"responsibleParty":48,"collaborators":25,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":25,"overallStatus":69,"whyStopped":25,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":25,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BI201335 low dose Efavirenz","EXPERIMENTAL","low dose Efavirenz",[13],"Drug: low dose",{"label":15,"type":10,"description":16,"interventionNames":17},"BI201335 high dose Efavirenz","normal dose Efavirenz",[13,18],"Drug: normal dose",[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","low dose","efavirenz single dosing once daily",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"normal dose","efavirenz once daily",[15],{"type":21,"name":22,"description":31,"armGroupLabels":32,"otherNames":25},"Efavirenz single dosing once daily",[9],[34],{"name":5,"affiliation":5,"role":35},"STUDY_CHAIR",[37],{"facility":38,"status":25,"city":39,"state":25,"zip":25,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"1220.20.41001 Boehringer Ingelheim Investigational Site","Basel","Switzerland","CH",{"type":43,"coordinates":44},"Point",[45,46],7.57327,47.55839,{"lat":46,"lon":45},{"type":49,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100161188","phase-1-evaluation-of-the-effect-of-multiple-dosing-with-bi-201335-on-cyp2b6-metabolism-and-effect-of-multiple-dosing-with-efavirenz-on-the-steady-state-pharmacokinetics-of-bi-201335-and-on-cyp3a45-metabolism-in-healthy-volunteers-100161188",true,"NCT01371006","Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4\u002F5 Metabolism in Healthy Volunteers","Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers","Inclusion criteria:\n\nHealthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9\n\nExclusion criteria:\n\n1. Any finding on medical examination and ECG (Electrocardiography) deviating from normal\n2. Active diseases\n3. History of photosensitivity or rash","ALL","18 Years","55 Years",{"count":61,"type":62},29,"ACTUAL","INTERVENTIONAL",[65],"PHASE1","Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.\n\nTo predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.",[68],"Healthy","COMPLETED","2015-07-03",{"date":72,"type":73},"2015-08-03","ESTIMATED",{"date":75,"type":25},"2011-06",{"name":5,"class":6},1]