[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100184633":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":40,"responsibleParty":48,"collaborators":39,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":39,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":39,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":69,"whyStopped":39,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Bial - Portela C S.A.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 BIA 2-093 + Oxcarbazepine","EXPERIMENTAL","Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine",[13,14],"Drug: BIA 2-093","Drug: Oxcarbazepine",{"label":16,"type":17,"description":18,"interventionNames":19},"Group 2 Oxcarbazepine + BIA 2-093","ACTIVE_COMPARATOR","Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","BIA 2-093","Tablets containing BIA 2-093 in doses of 300 and 600 mg",[9,16],[27],"Eslicarbazepine acetate",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Oxcarbazepine","Tablets containing 300 mg and 600 mg of Trileptal®",[9,16],[33],"Trileptal®",[35],{"name":36,"affiliation":37,"role":38},"Manuel Vaz-da-Silva, MD, PhD","BIAL - Portela & Cª S.A","PRINCIPAL_INVESTIGATOR",null,[41],{"facility":42,"status":39,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":39,"geoPoint":39,"contacts":39},"BIAL - Portela & Cª - Human Pharmacology Unit (UFH)","S. Mamede Do Coronado","Trofa","4745-457","Portugal","PT",{"type":49,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100184633","phase-1-tolerability-and-pharmacokinetics-of-a-single-900-mg-oral-dose-of-bia-2-093-and-oxcarbazepine-in-healthy-volunteers-100184633",true,"NCT01678976","Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers","Inclusion Criteria:\n\n* Male or female subjects aged between 18 and 45 years, inclusive.\n* Subjects of body mass index (BMI) between 19 and 28 kg\u002Fm2, inclusive.\n* Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.\n* Subjects who had clinical laboratory tests acceptable.\n* Subjects who were negative for HBs Ag, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.\n* Subjects who were negative for alcohol and drugs of abuse at screening and admission.\n* Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.\n* Subjects who were able and willing to give written informed consent.\n* In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.\n* In case of female volunteers, subjects who had a negative pregnancy test at screening and admission\n\nExclusion Criteria:\n\n* Subjects who did not conform to the above inclusion criteria.\n* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.\n* Subjects who had a clinically relevant surgical history.\n* Subjects who had a clinically relevant family history.\n* Subjects who had a history of relevant atopy.\n* Subjects who had a history of relevant drug hypersensitivity.\n* Subjects who had a history of alcoholism or drug abuse.\n* Subjects who consumed more than 21 units of alcohol a week.\n* Subjects who had a significant infection or known inflammatory process on screening and\u002For admission.\n* Subjects who had acute gastrointestinal symptoms at the time of screening and\u002For admission (e.g., nausea, vomiting, diarrhoea, heartburn).\n* Subjects who had used prescription drugs within 4 weeks of first dosing.\n* Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.\n* Subjects who had used any investigational drug and\u002For participated in any clinical trial within 2 months of their first admission.\n* Subjects who had previously received BIA 2-093.\n* Subjects who had donated and\u002For received any blood or blood products within the previous 2 months prior to screening.\n* Subjects who were vegetarians, vegans and\u002For had medical dietary restrictions.\n* Subjects who could not communicate reliably with the investigator.\n* Subjects who were unlikely to co-operate with the requirements of the study.\n* Subjects who were unwilling or unable to give written informed consent.\n* In case of female volunteers, subjects who were pregnant or breast-feeding.\n* In case of female volunteers, subjects who were of childbearing potential and did not use an approved effective contraceptive method or used oral contraceptives.","ALL","18 Years","45 Years",{"count":60,"type":61},13,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.",[67],"Epilepsy",[27,67,29],"COMPLETED","2014-12-19",{"date":72,"type":73},"2015-01-08","ESTIMATED",{"date":75,"type":39},"2002-03",{"date":77,"type":61},"2002-04",{"name":5,"class":6},1]