[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100222304":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":27,"collaborators":11,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":11,"eligibilityCriteria":35,"healthyVolunteers":36,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":11,"leadSponsor":56,"locationsCount":11},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BIBR 953 ZW Intravenously","EXPERIMENTAL",null,[13],"Drug: BIBR 953 ZW Intravenously",{"label":15,"type":16,"description":11,"interventionNames":17},"BIBR 1048 Oral Solution","ACTIVE_COMPARATOR",[18],"Drug: BIBR 1048 Oral Solution",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","5 mg, 2.8 MBq (76 µCi)",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"200 mg free base, 2.8 MBq (76 µCi)",[15],{"type":28,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100222304","phase-1-metabolism-and-pharmacokinetics-of-14c-bibr-953-zw-after-administration-of-single-doses-of-14c-bibr-953-zw-intravenously-or-14c-bibr-1048-oral-solution-in-healthy-male-volunteers-100222304",false,"NCT02171442","Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of [14C]-BIBR 953 ZW Intravenously or [14C]-BIBR 1048 Oral Solution in Healthy Male Volunteers","Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of 5 mg [14C]-BIBR 953 ZW Intravenously or 200 mg [14C]-BIBR 1048 Oral Solution in a Group Comparison Design in 12 Healthy Male Volunteers.","Inclusion Criteria:\n\n* Healthy male subjects as determined by results of screening\n* Signed written informed consent from each subject in accordance with the regulatory and legal requirements of the UK\n* Age between 30 and 55 years of age\n* Body Mass Index (BMI) of between 18.5 and 29.9 kg\u002Fm²\n\nExclusion Criteria:\n\n* Any of the findings from the medical examination (including BP, pulse rate and ECG) deviated from normal or were of clinical relevance\n* History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders\n* History of relevant orthostatic hypotension, fainting spells and blackouts, or volunteers with diseases of the central nervous system (such as epilepsy) or psychiatric disorders\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders\n* Chronic or relevant acute infections\n* History of allergy\u002Fhypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the principal investigator\n* History of any bleeding disorder including prolonged or habitual bleeding\n* History of other hematologic disease\n* History of cerebral bleeding (e.g. after a car accident)\n* History of craniocerebral trauma\n* Intake of drugs with a long half life (≥ 24h) within 1 month prior to administration\n* Any drugs which may have had an influence on the results of the trial within 10 days prior to administration or during the trial\n* Any volunteers who had participated in another trial with an investigational drug within 3 months ( 4 months if the drug was a new chemical entity) prior to administration or during the trial\n* Exposition to radiation in the previous 12 months (i.e. serial x-rays, CT scan or barium meal)\n* Smoker\n* Alcohol abuse (\\> 60 g\u002Fday)\n* Drug abuse\n* Blood donation within 12 weeks prior to administration or during the trial\n* Any excessive physical activities within 5 days prior to administration or during the trial\n* Any laboratory value outside the clinically accepted reference range\n* History of familial bleeding disorder\n* Platelets \\> 150 x 10-9 \u002Fl\n* Unable to defecate at least once a day every two days",true,"MALE","30 Years","55 Years",{"count":41,"type":42},10,"ACTUAL","INTERVENTIONAL",[45],"PHASE1","The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS and BIBR 953 ZW in man.",[48],"Healthy","COMPLETED","2014-06-20",{"date":52,"type":53},"2014-06-24","ESTIMATED",{"date":55,"type":11},"2002-04",{"name":5,"class":6}]