[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100282231":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":42,"locations":53,"responsibleParty":67,"collaborators":42,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":42,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":42,"overallStatus":91,"whyStopped":42,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Cape Town","OTHER",[8,15,18,21,24,27],{"label":9,"type":6,"description":10,"interventionNames":11},"sequence 1","Rifafour e-275®, Sanofi-Aventis \u002FRimactazid 150\u002F75, Sandoz\u002F Rimactane® 150 mg capsules, Sandoz\n\n\\- 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences",[12,13,14],"Drug: Rimactane","Drug: Rifafour e-275","Drug: Rimactazid 150\u002F75",{"label":16,"type":6,"description":10,"interventionNames":17},"sequence 2",[12,13,14],{"label":19,"type":6,"description":10,"interventionNames":20},"sequence 3",[12,13,14],{"label":22,"type":6,"description":10,"interventionNames":23},"sequence 4",[12,13,14],{"label":25,"type":6,"description":10,"interventionNames":26},"sequence 5",[12,13,14],{"label":28,"type":6,"description":10,"interventionNames":29},"sequence 6",[12,13,14],[31,38,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Rimactane","150 mg capsules, Sandoz MCC registration # A\u002F20.2.3\u002F784",[9,16,19,22,25,28],[37],"Rifampicin",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Rifafour e-275","Rifampicin\u002Fisoniazid\u002Fpyrazinamide\u002Fethambutol 150\u002F75\u002F400\u002F275 mg This 4-drug FDC is the most widely used 4-drug FDC in South Africa with an estimated 100% of the SA DOH tender.",[9,16,19,22,25,28],null,{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Rimactazid 150\u002F75","Rifampicin\u002Fisoniazid 150\u002F75 mg This 2-drug FDC is one of 2 widely used 2-drug FDCs in South Africa, with an estimated 30% of the SA DOH tender. Rifinah® made by Sanofi-Aventis holds about 70% of the tender, however as the Sanofi-Aventis 4-drug FDC will also be evaluated.",[9,16,19,22,25,28],[48],"Rifampicin \u002F Isoniazid",[50],{"name":51,"affiliation":5,"role":52},"Helen M McIlleron, PhD","PRINCIPAL_INVESTIGATOR",[54],{"facility":55,"status":42,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":42},"Clinical Research Centre","Cape Town","Western Cape","7725","South Africa","ZA",{"type":62,"coordinates":63},"Point",[64,65],18.42322,-33.92584,{"lat":65,"lon":64},{"type":52,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Helen Margaret McIlleron","Senior Research Officer","100282231","phase-1-the-bioavailability-of-rifampicin-in-fdcs-widely-used-in-south-africa-to-treat-drug-susceptible-tb-100282231",false,"NCT02953847","The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)","The Bioavailability of Rifampicin in Fixed Dose Combinations (FDCs) Widely Used in South Africa to Treat Drug-susceptible Tuberculosis (TB)","BIO3FDC","Inclusion\n\n* You need to be between the ages of 18-55 years\n* Have a Body mass index (BMI) of 19-30 kg\u002Fm2\n* Weigh 45 kg or more\n* Be a non-smoker\n* Be found to be in normal health on history and examination\n* To have normal blood and urine test results\n* If you are a woman of child-bearing age, you need to be prepared to not have sexual intercourse, or use a safe form of contraception, until the end of the study\n\nExclusion\n\n* You are unable to fully understand and comply with the study procedures, requirements and time commitments.\n* Are currently enrolled in any other study evaluating drugs, biologics or devices\n* You have TB, or have had TB before\n* You abuse or have abused drugs or alcohol\n* You have, or have had, drug allergy, severe asthma, or active or recurrent allergic disease\n* You are pregnant",true,"ALL","18 Years","55 Years",{"count":83,"type":84},21,"ACTUAL","INTERVENTIONAL",[87],"PHASE1","3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing FDCs vs a single drug comparator in healthy volunteers",[90],"Tuberculosis","COMPLETED","2017-05-09",{"date":94,"type":84},"2017-05-10",{"date":96,"type":84},"2016-11",{"date":98,"type":84},"2017-02",{"name":5,"class":6},1]