[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100229408":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":32,"collaborators":23,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":23,"eligibilityCriteria":40,"healthyVolunteers":41,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":23,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":23,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":23,"leadSponsor":61,"locationsCount":23},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Tamsulosin + Paroxetine","EXPERIMENTAL","Tamsulosin: q.d on day 1\n\nParoxetine: higher dose q.d. on days -7 to 2 q.d., lower dose on days -10 to -8 and 3 to 5",[13,14],"Drug: Tamsulosin","Drug: Paroxetine",{"label":16,"type":17,"description":18,"interventionNames":19},"Tamsulosin","ACTIVE_COMPARATOR","Tamsulosin: q.d on day 1",[13],[21,27],{"type":22,"name":16,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG",null,[16,9],[26],"Alna®",{"type":22,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"Paroxetine",[9],[31],"Tagonis®",{"type":33,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100229408","phase-1-study-to-investigate-the-effect-of-paroxetine-mediated-cyp2d6-inhibition-on-the-pharmacokinetics-of-tamsulosin-in-healthy-male-volunteers-100229408",false,"NCT02264184","Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Pharmacokinetics of Tamsulosin in Healthy Male Volunteers","An Open Label Randomized Two-way Crossover Study to Investigate the Effect of Paroxetine Mediated CYP2D6 Inhibition on the Single Oral Dose Pharmacokinetics of Tamsulosin in Healthy Male Volunteers (CYP2D6 Extensive Metabolizers)","Inclusion Criteria:\n\nAll participants in the study are\n\n* Healthy males\n* Ranging from 21 to 50 years of age\n* Body mass index (BMI) within 18.5 to 29.9 kg\u002Fm2\n* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* History of orthostatic hypotension, fainting spells or blackouts\n* Chronic or clinically relevant acute infections\n* History of allergy\u002Fhypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Intake of drugs with a long half-life (\\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study\n* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study\n* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or \\> 3 cigars of \\> 3 pipes\u002Fday)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g\u002Fday)\n* Drug abuse\n* Blood donation (\\> 100 mL within four weeks prior to administration or during the trial)\n* Any laboratory value outside the reference range if indicative of underlying disease or poor health\n* Excessive physical activities within the last week before the trial or during the trial\n* Hypersensitivity to treatment medication and\u002For related drugs of these classes\n* Non extensive metabolizer (EM) for CYP2D6",true,"MALE","21 Years","50 Years",{"count":46,"type":47},24,"ACTUAL","INTERVENTIONAL",[50],"PHASE1","Study to investigate the effect of CYP2D6 inhibition by paroxetine on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability",[53],"Healthy","COMPLETED","2014-10-14",{"date":57,"type":58},"2014-10-15","ESTIMATED",{"date":60,"type":23},"2008-09",{"name":5,"class":6}]