[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100184907":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":28,"locations":37,"responsibleParty":49,"collaborators":28,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":28,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":28,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":75,"whyStopped":28,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Swedish Orphan Biovitrum","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Orfadin capsules, fasting","ACTIVE_COMPARATOR","Orfadin capsules, single dose, 30 mg",[13],"Drug: Nitisinone, capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Orfadin suspension, fasting","EXPERIMENTAL","Orfadin suspension 4 mg\u002FmL, single dose 30 mg (7,5 mL)",[19],"Drug: Nitisinone, suspension",{"label":21,"type":16,"description":22,"interventionNames":23},"Orfadin suspension, with food","Orfadin suspension 4mg\u002FmL, single dose 30 mg (7,5 mL)",[19],[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":28},"DRUG","Nitisinone, capsule",null,[9],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":28},"Nitisinone, suspension",[15,21],[34],{"name":35,"affiliation":5,"role":36},"Erik Brouwer, MD","STUDY_DIRECTOR",[38],{"facility":39,"status":28,"city":40,"state":28,"zip":28,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":28},"Pharmaceutical Research Associates Group B.V (PRA)","Zuidlaren","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],6.68194,53.09417,{"lat":47,"lon":46},{"type":50,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100184907","phase-1-bioequivalence-of-orfadin-suspension-compared-to-orfadin-capsules-and-the-effect-of-food-on-the-bioavailability-of-the-suspension-100184907",true,"NCT01682538","Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension","A Study to Evaluate the Bioequivalence of Orfadin Suspension 4 mg\u002FmL Compared to Orfadin Capsules 10 mg, and the Effect of Food on the Bioavailability of the Suspension. An Open-label, Randomized, Cross-over, Single-dose Study in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy male volunteers\n* Age: 18-55 years, inclusive\n* BMI: 18,5-30,0 kg\u002Fm2, inclusive\n\nExclusion Criteria:\n\n* heavy smokers\n* Consumption of more than 4 cups of coffee per day.\n* History of drug and\u002For alcohol abuse.\n* Positive drug screen or alcohol breath test.\n* Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.\n* Enrollment in another concurrent clinical study\n* Intake of an investigational medicinal product within three months prior to inclusion in this study.\n* Donation of more than 50 mL of blood within 60 days prior to drug administration\n* Donation of more than 1,5 liters of blood in the 10 months prior to first drug administration.","MALE","18 Years","55 Years",{"count":62,"type":63},12,"ACTUAL","INTERVENTIONAL",[66],"PHASE1","The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.",[69],"Healthy Volunteers",[71,72,73,74],"Orfadin","Nitisinone","Bioequivalence","Bioavailability","COMPLETED","2014-02-20",{"date":78,"type":79},"2014-03-17","ESTIMATED",{"date":81,"type":28},"2012-08",{"date":83,"type":63},"2012-10",{"name":5,"class":6},1]