[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100170823":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":26,"locations":27,"responsibleParty":40,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Takeda","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1 (A-B-C)","EXPERIMENTAL","* A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1\n* B: single dose of 400 μg INFS (100 μL), administered 4 hours after the first treatment\n* C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 24 hours after the first treatment (Day 2)",[13],"Drug: INFS (Intranasal Fentanyl Spray)",{"label":15,"type":10,"description":16,"interventionNames":17},"Sequence 2 (A-C-B)","* A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1\n* C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 4 hours after the first treatment\n* B: single dose of 400 μg INFS (100 μL), administered 24 hours after the first treatment (Day 2)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","INFS (Intranasal Fentanyl Spray)","Intranasal Fentanyl Spray",[9,15],[25],"(Instanyl®)",null,[28],{"facility":29,"status":26,"city":30,"state":26,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":26},"Nycomed Investigational Site","Mannheim","68157","Germany","DE",{"type":35,"coordinates":36},"Point",[37,38],8.46694,49.4891,{"lat":38,"lon":37},{"type":41,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100170823","phase-1-a-trial-to-investigate-the-pharmacokinetics-pk-of-single-doses-of-200-g-400-g-and-2-x-400-g-of-intranasal-fentanyl-spray-infs-in-healthy-subjects-100170823",false,"NCT01497288","A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects","An Open Label, Randomised, Single-centre, Two Sequence, Cross-over Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects Using a Population PK Approach","PK400 INFS","Eligibility Criteria:\n\nHealthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg\u002Fm2 and a minimum weight of 50 kg.","ALL","18 Years","55 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58],"PHASE1","The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg\u002Fdose INFS, 400 µg\u002Fdose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.",[61],"Healthy Volunteers",[63,64],"Intranasal fentanyl spray","Population PK","COMPLETED","2012-09-28",{"date":68,"type":55},"2012-10-02",{"date":70,"type":26},"2011-11",{"date":72,"type":73},"2011-12","ACTUAL",{"name":5,"class":6},1]