Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
Study NCT ID:
NCT00971295
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2009-09-02
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
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Portela & Cª, S.A.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Metformin + ESL', 'description': 'Metformin HCl 850 mg, ESL 1200 mg\n\nMetformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days', 'otherNumAtRisk': 20, 'otherNumAffected': 9, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metformin', 'description': 'Metformin HCl 850 mg', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythropapular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Herpes labialis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Right forearm ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Recurrent vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bilateral popliteal erythromacular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eczema aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eyelid hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + ESL', 'description': 'Metformin HCl 850 mg, ESL 1200 mg\n\nMetformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin HCl 850 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1091', 'spread': '27.6', 'groupId': 'OG000'}, {'value': '1224', 'spread': '21.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Maximum Observed Plasma Metformin Concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax - Time of Occurrence of Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + ESL', 'description': 'Metformin HCl 850 mg, ESL 1200 mg\n\nMetformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin HCl 850 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'spread': '46.9', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '40.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'time of occurrence of maximum observed plasma metformin concentration', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + ESL', 'description': 'Metformin HCl 850 mg, ESL 1200 mg\n\nMetformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin HCl 850 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '7362', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '7688', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'area under the plasma metformin concentration from time zero to infinity', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence A', 'description': 'Treatment Sequence A:\n\nEslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period\n\n850 mg metformin hydrochloride, 1200 mg ESL'}, {'id': 'FG001', 'title': 'Treatment Sequence B', 'description': 'Treatment Sequence B:\n\nMetformin period followed by washout period followed by Metformin + Eslicarbazepine acetate\n\n850 mg metformin hydrochloride, 1200 mg ESL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin + ESL', 'description': 'Metformin HCl 850 mg, ESL 1200 mg\n\nMetformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', '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': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2009-09-02', 'resultsFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2009-09-02', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-15', 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Plasma Concentration', 'timeFrame': '3 weeks', 'description': 'Maximum Observed Plasma Metformin Concentration'}], 'secondaryOutcomes': [{'measure': 'Tmax - Time of Occurrence of Cmax', 'timeFrame': '3 weeks', 'description': 'time of occurrence of maximum observed plasma metformin concentration'}, {'measure': 'AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity', 'timeFrame': '3 weeks', 'description': 'area under the plasma metformin concentration from time zero to infinity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['eslicarbazepine acetate', 'zebinix', 'metformin'], 'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '19356391', 'type': 'RESULT', 'citation': 'Rocha JF, Vaz-da-Silva M, Almeida L, Falcao A, Nunes T, Santos AT, Martins F, Fontes-Ribeiro C, Macedo T, Soares-da-Silva P. Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. Int J Clin Pharmacol Ther. 2009 Apr;47(4):255-61. doi: 10.5414/cpp47255.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects aged between 18 and 45 years, inclusive.\n* Body mass index (BMI) between 19 and 30 kg/m2, inclusive.\n* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.\n* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening\n* 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 who smoke ≤ 10 cigarettes or equivalent per day.\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 used one of the following methods of contraception: double barrier or intrauterine device.\n* (If female) 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 drug hypersensitivity.\n* History of alcoholism or drug abuse.\n* Consumed more than 14 units of alcohol a week.\n* Significant infection or known inflammatory process at 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* Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.\n* Used any investigational drug or participated in any clinical trial within 6 months prior to screening.\n* Participated in more than 2 clinical trials within the 12 months prior to screening.\n* Donated or received any blood or blood products within the 3 months prior to screening.\n* Vegetarians, vegans or with medical dietary restrictions.\n* Could not 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) Pregnant or breast-feeding.\n* (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives."}, 'identificationModule': {'nctId': 'NCT00971295', 'briefTitle': 'Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BIA-2093-125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence A', 'description': 'Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period', 'interventionNames': ['Drug: Metformin', 'Drug: Eslicarbazepine acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence B', 'description': 'Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period', 'interventionNames': ['Drug: Metformin', 'Drug: Eslicarbazepine acetate']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': '850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days', 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B']}, {'name': 'Eslicarbazepine acetate', 'type': 'DRUG', 'otherNames': ['Zebinix'], 'armGroupLabels': ['Treatment Sequence A', 'Treatment Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mamede Do Coronado', 'country': 'Portugal', 'facility': 'Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA,'}], 'overallOfficials': [{'name': 'Manuel Vaz-da-Silva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BIAL - Portela & Ca, S.A'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}