[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224056":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":39,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":11,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":11,"leadSponsor":59,"locationsCount":11},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Telmisartan low + amlodipine","EXPERIMENTAL",null,[13,14],"Drug: Telmisartan low","Drug: amlodipine",{"label":16,"type":10,"description":11,"interventionNames":17},"Telmisartan high + amlodipine",[18,14],"Drug: Telmisartan high",[20,24,27],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":11},"DRUG","Telmisartan low",[9],{"type":21,"name":25,"description":11,"armGroupLabels":26,"otherNames":11},"Telmisartan high",[16],{"type":21,"name":28,"description":11,"armGroupLabels":29,"otherNames":11},"amlodipine",[16,9],{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100224056","phase-1-safety-tolerability-and-pharmacokinetics-of-single-and-multiple-oral-doses-of-40-mg-telmisartan5-mg-amlodipine-and-80-mg-telmisartan5-mg-amlodipine-in-healthy-male-volunteers-100224056",false,"NCT02194309","Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan\u002F5 mg Amlodipine and 80 mg Telmisartan\u002F5 mg Amlodipine in Healthy Male Volunteers","Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan\u002F5 mg Amlodipine and 80 mg Telmisartan\u002F5 mg Amlodipine (Free Dose Combination) in Healthy Male Volunteers","Inclusion Criteria:\n\nHealthy male volunteers according to the following criteria:\n\n1. No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests\n2. Age ≥20 and Age ≤35 years\n3. Body weight ≥50 kg\n4. Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg\u002Fm2\n5. Signed and dated written informed consent before admission to the trial\n\nExclusion Criteria:\n\n1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n3. Chronic or relevant acute infections\n4. Any clinical relevant findings of the laboratory test deviating from normal\n5. Positive result for either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test\n6. History of surgery of gastrointestinal tract (except appendectomy)\n7. History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varied by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varied by ≥10 mmHg from mean supine DBP), fainting spells or blackouts\n8. History of hepatic dysfunction (e.g., biliary cirrhosis, cholestasis)\n9. History of serious renal dysfunction\n10. History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney\n11. History of cerebrovascular disorder\n12. History of hyperkalemia\n13. Known hypersensitivity to any component of the formulation, or to any other Angiotensin Receptor Blocker (ARB), angiotensin converting enzyme or dihydropyridine\n14. Intake of drugs with a long half-life (≥24 hours) within at least one month or less than 10 half-lives of the respective drug before administration or during the trial\n15. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days before administration or during the trial\n16. Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug before administration\n17. Smoker (≥20 cigarettes\u002Fday)\n18. Alcohol abuse (60 g or more ethanol\u002Fday: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)\n19. Drug abuse\n20. Blood donation (more than 100 mL within 4 weeks before administration or during the trial)\n21. Excessive physical activities (within 1 week before administration or during the trial)\n22. Intake of alcohol within 2 days before administration\n23. Inability to comply with dietary regimen of trial centre\n24. Intake of any drugs\u002Fsupplements with ingredient of hypericum perforatum (citrus fruits, Sevilla orange) within 5 days prior to administration\n25. Inability to refrain from smoking on trial days",true,"MALE","20 Years","35 Years",{"count":44,"type":45},24,"ACTUAL","INTERVENTIONAL",[48],"PHASE1","To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan\u002F5 mg amlodipine and 80 mg telmisartan\u002F5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan\u002F5 mg amlodipine and 80 mg telmisartan\u002F5 mg amlodipine once daily for 10 days",[51],"Healthy","COMPLETED","2014-07-17",{"date":55,"type":56},"2014-07-18","ESTIMATED",{"date":58,"type":11},"2006-09",{"name":5,"class":6}]