Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT00987558
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C416835', 'term': 'eslicarbazepine acetate'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jose.rocha@bial.com', 'title': 'Head of Clinical Research', 'organization': 'Bial - Portela & Cª, S.A.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'Simvastatin 80 mg', 'otherNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Eslicarbazepine Acetate', 'description': 'eslicarbazepine acetate 800 mg', 'otherNumAtRisk': 30, 'otherNumAffected': 23, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Eslicarbazepine Acetate + Simvastatin', 'description': 'Simvastatin 80 mg + eslicarbazepine acetate 800 mg', 'otherNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash morbilliform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Simvastatin Cmax (Maximum Plasma Concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Reference)', 'description': 'Simvastatin 80 mg'}, {'id': 'OG001', 'title': 'ESL + Simvastatin (Test)', 'description': 'Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '6.89', 'spread': '5.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'Simvastatin (Reference) ESL + Simvastatin (Test)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Simvastatin Tmax (Time of Occurrence of Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Reference)', 'description': 'Simvastatin 80 mg'}, {'id': 'OG001', 'title': 'ESL + Simvastatin (Test)', 'description': 'Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '3.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'Simvastatin (Reference) ESL + Simvastatin (Test)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Simvastatin AUC0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Reference)', 'description': 'Simvastatin 80 mg'}, {'id': 'OG001', 'title': 'ESL + Simvastatin (Test)', 'description': 'Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '93.9', 'spread': '47.7', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '22.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification\n\nSimvastatin (Reference) ESL + Simvastatin (Test)', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin (Reference)', 'description': 'Simvastatin 80 mg'}, {'id': 'OG001', 'title': 'ESL + Simvastatin (Test)', 'description': 'Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'spread': '68.6', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '46.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 14', 'description': 'Simvastatin (Reference) ESL + Simvastatin (Test)', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin, Then ESL + Simvastatin', 'description': 'Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day'}, {'id': 'FG001', 'title': 'ESL, Then Simvastatin', 'description': 'Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Simvastatin', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Washout', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Eslicarbazepine Acetate + Simvastatin', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Eslicarbazepine Acetate + Simvastatin', 'description': 'Simvastatin 80 mg + eslicarbazepine acetate 800 mg\n\nSimvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days - separated by a washout period of 3 weeks or more.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2009-09-30', 'resultsFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-12', 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Simvastatin Cmax (Maximum Plasma Concentration)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Simvastatin (Reference) ESL + Simvastatin (Test)'}, {'measure': 'Simvastatin Tmax (Time of Occurrence of Cmax)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Simvastatin (Reference) ESL + Simvastatin (Test)'}, {'measure': 'Simvastatin AUC0-t', 'timeFrame': 'Day 1 and Day 14', 'description': 'AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification\n\nSimvastatin (Reference) ESL + Simvastatin (Test)'}, {'measure': 'Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Simvastatin (Reference) ESL + Simvastatin (Test)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eslicarbazepine acetate', 'simvastatin'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.', 'detailedDescription': 'This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days -, separated by a washout period of 3 weeks or more'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects aged 18 to 45 years, inclusive\n* Body mass index (BMI) between 18 and 30 kg/m2, inclusive\n* Healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG; negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening; clinical laboratory test results clinically acceptable at screening and admission to each treatment period;\n* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period\n* Non-smokers or ex-smokers\n* Able and willing to give written informed consent;\n* If female, not of childbearing potential by reason of surgery or, if of childbearing potential, she uses one of the following methods of contraception: double barrier method: 1 male barrier method \\[male condom\\] plus 1 female barrier method (diaphragm, spermicide, or intrauterine device);\n* If female, has a negative urine pregnancy test at screening and admission to each treatment period.\n\nExclusion Criteria:\n\n* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders\n* Clinically relevant surgical history;\n* History of relevant atopy or any drug hypersensitivity (including known hypersensitivity to ESL or other carboxamide derivatives, simvastatin or other statins or any of its excipients\n* History of fibromyalgia, myopathy, rhabdomyolysis or unexplained muscle pain\n* Second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator\n* History of alcoholism or drug abuse\n* Consume more than 14 units of alcohol a week\n* Significant infection or known inflammatory process on screening or admission to each treatment period\n* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period\n* Use of medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion\n* Have donated or received any blood or blood products within the 3 months prior to screening\n* Vegetarians, vegans or have other medical dietary restrictions\n* Cannot communicate reliably with the investigator\n* Unlikely to co-operate with the requirements of the study\n* Unwilling or unable to give written informed consent\n* If female, is pregnant or breast-feeding\n* If female, is of childbearing potential and does not use an approved effective contraceptive method (double-barrier method: 1 male barrier method \\[male condom\\] plus 1 female barrier method (diaphragm, spermicide, or intra-uterine device) or uses hormonal contraceptives\n* Have received an investigational drug within 3 months of screening or is currently participating in another study"}, 'identificationModule': {'nctId': 'NCT00987558', 'briefTitle': 'Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BIA-2093-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence A', 'description': 'Simvastatin 80mg treatment period followed by Simvastatin 80 mg + eslicarbazepine acetate 800 mg treatment period', 'interventionNames': ['Drug: Eslicarbazepine acetate', 'Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence B', 'description': 'Simvastatin 80mg + eslicarbazepine acetate 800 mg treatment period followed by Simvastatin 80 mg treatment period', 'interventionNames': ['Drug: Eslicarbazepine acetate', 'Drug: Simvastatin']}], 'interventions': [{'name': 'Eslicarbazepine acetate', 'type': 'DRUG', 'otherNames': ['Zebinix'], 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B']}, {'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F-35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Biotrial, 7-9 rue Jean-Louis Bertrand', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Marie Claude Homery, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biotrial, 7-9, rue Jean-Louis Bertrand, F-35000 Rennes, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}