Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-29 @ 2:17 AM
Study NCT ID:
NCT01658202
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotine Patch Bioequivalence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile', 'timeFrame': 'Blood samples will be collected on Days 1, 3, 5 and 7', 'description': 'Pharmacokinetic profile of nicotine following a single patch application by measuring Maximum Plasma Concentration, Time of Maximum Concentration, Area under the nicotine plasma concentration curve, for each test and reference formulations'}], 'secondaryOutcomes': [{'measure': 'Clinical safety (reported adverse events)', 'timeFrame': 'up to day 9', 'description': 'General and local safety by evaluating the number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram, haematology and biochemistry'}]}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Nicotine', 'Tobacco Use Disorder', 'Central Nervous System Agents'], 'conditions': ['Healthy Smokers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.\n\n4 single 24hour applications separated by 48hour intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subject aged 18 to 45 years (inclusive)\n* Current Smoker of \\>or = 5 and \\< or = 15 cigarettes/day\n* Fagerström score \\< or =5 at selection\n* Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.\n\nExclusion Criteria:\n\n* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator\n* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch"}, 'identificationModule': {'nctId': 'NCT01658202', 'briefTitle': 'Nicotine Patch Bioequivalence Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'orgStudyIdInfo': {'id': 'V00116 TD 1 04'}, 'secondaryIdInfos': [{'id': '2011-006212-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence 1', 'description': 'After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.\n\nEach patch will be applied for 24h.', 'interventionNames': ['Drug: V0116 transdermal patch (Test treatment )', 'Drug: Nicotine transdermal patch (Reference Treatment )']}, {'type': 'OTHER', 'label': 'Sequence 2', 'description': 'After a 24h washout period free of any nicotine exposure, subjects will be randomly assigned to one of 2 treatment-sequence groups, separated by a 48h-intervals.\n\nEach patch will be applied for 24h.', 'interventionNames': ['Drug: V0116 transdermal patch (Test treatment )', 'Drug: Nicotine transdermal patch (Reference Treatment )']}], 'interventions': [{'name': 'V0116 transdermal patch (Test treatment )', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}, {'name': 'Nicotine transdermal patch (Reference Treatment )', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1', 'Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}