[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224759":3},{"organization":4,"armGroups":7,"interventions":21,"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",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Lacidipine","EXPERIMENTAL",null,[13],"Drug: Lacidipine",{"label":15,"type":10,"description":11,"interventionNames":16},"Telmisartan",[17],"Drug: Telmisartan",{"label":19,"type":10,"description":11,"interventionNames":20},"Lacidipine + Telmisartan",[13,17],[22,25],{"type":23,"name":9,"description":11,"armGroupLabels":24,"otherNames":11},"DRUG",[9,19],{"type":23,"name":15,"description":11,"armGroupLabels":26,"otherNames":11},[19,15],{"type":28,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100224759","phase-1-tolerability-and-pharmacokinetics-of-lacidipine-with-and-without-the-co-administration-of-telmisartan-in-female-and-male-healthy-subjects-100224759",false,"NCT02203500","Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects","Tolerability and Pharmacokinetics of 80 mg Telmisartan and 6 mg Lacidipine Alone and in Combination After 7 Days Treatment. An Open Randomised Three-way Cross-over Trial in Female and Male Healthy Subjects","Inclusion Criteria:\n\n* Healthy male and female Caucasian subjects as determined by results of screening\n* Written informed consent in accordance with Good Clinical Practice and local legislation given\n* Age \\>= 18 and \\\u003C= 50 years\n* Broca \\>= -20% and \\\u003C= + 20%\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Surgery of gastrointestinal tract (except appendectomy)\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders\n* History of orthostatic hypotension, fainting spells or blackouts\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 investigator\n* Intake of drugs with a long half-life (\\> 24 hours) (\\\u003C= 1 month prior to administration or during the trial)\n* Use of any drugs which might influence the results of the trial (\\\u003C= 10 days prior to administration or during the trial)\n* Participation in another trial with an investigational drug (\\\u003C= 2 months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or \\> 3 cigars or \\> 3 pipes\u002Fday)\n* Inability to refrain from smoking on study days\n* Alcohol abuse (\\> 60g\u002Fday)\n* Drug abuse\n* Blood donation \\> 100 ml (\\\u003C= 4 weeks prior to administration or during the trial)\n* Any laboratory value outside the reference range of clinical relevance\n* Female only:\n\n  * no reliable contraception (reliable are: oral contraceptives, 3-month injection, Intrauterine devices (IUD), sterilization)\n  * Pregnancy or breast feeding period",true,"ALL","18 Years","50 Years",{"count":41,"type":42},26,"ACTUAL","INTERVENTIONAL",[45],"PHASE1","The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without the co-administration of lacidipine",[48],"Healthy","COMPLETED","2014-08-05",{"date":52,"type":53},"2014-08-06","ESTIMATED",{"date":55,"type":11},"1998-10",{"name":5,"class":6}]