Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-01 @ 6:20 PM
Study NCT ID:
NCT01084603
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhauze@its.jnj.com', 'phone': '928-277-0715', 'title': 'Joyce Hauze, Sr Specialist, Clinical Research Operations', 'organization': 'J&J Consumer and Personal Products Worldwide'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Nicotine 1', 'description': '1 administration of 1 mg', 'otherNumAtRisk': 41, 'otherNumAffected': 11, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Nicotine 2', 'description': '2 administrations of 1 mg', 'otherNumAtRisk': 42, 'otherNumAffected': 11, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Oral Nicotine 4', 'description': '4 administrations of 1 mg', 'otherNumAtRisk': 43, 'otherNumAffected': 24, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NiQuitinTM Lozenge 4 mg', 'description': '1 NiQuitinTM nicotine lozenge 4 mg', 'otherNumAtRisk': 43, 'otherNumAffected': 7, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes', 'otherNumAtRisk': 42, 'otherNumAffected': 9, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nicotine 1', 'description': '1 administration of 1 mg'}, {'id': 'OG001', 'title': 'Oral Nicotine 2', 'description': '2 administrations of 1 mg'}, {'id': 'OG002', 'title': 'Oral Nicotine 4', 'description': '4 administrations of 1 mg'}, {'id': 'OG003', 'title': 'NiQuitinTM Lozenge 4 mg', 'description': '1 NiQuitinTM nicotine lozenge 4 mg'}, {'id': 'OG004', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.04', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '8.63', 'spread': '2.96', 'groupId': 'OG002'}, {'value': '6.44', 'spread': '2.06', 'groupId': 'OG003'}, {'value': '7.36', 'spread': '2.66', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During 12 hours after start of administration', 'description': 'Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)', 'unitOfMeasure': '(ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Nicotine Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nicotine 1', 'description': '1 administration of 1 mg'}, {'id': 'OG001', 'title': 'Oral Nicotine 2', 'description': '2 administrations of 1 mg'}, {'id': 'OG002', 'title': 'Oral Nicotine 4', 'description': '4 administrations of 1 mg'}, {'id': 'OG003', 'title': 'NiQuitinTM Lozenge 4 mg', 'description': '1 NiQuitinTM nicotine lozenge 4 mg'}, {'id': 'OG004', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.42', 'groupId': 'OG002'}, {'value': '0.29', 'spread': '0.20', 'groupId': 'OG003'}, {'value': '0.29', 'spread': '0.20', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During 10 minutes after start of administration', 'description': 'Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)', 'unitOfMeasure': '(h*ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nicotine 1', 'description': '1 administration of 1 mg'}, {'id': 'OG001', 'title': 'Oral Nicotine 2', 'description': '2 administrations of 1 mg'}, {'id': 'OG002', 'title': 'Oral Nicotine 4', 'description': '4 administrations of 1 mg'}, {'id': 'OG003', 'title': 'NiQuitinTM Lozenge 4 mg', 'description': '1 NiQuitinTM nicotine lozenge 4 mg'}, {'id': 'OG004', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '1.50'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '1.00'}, {'value': '0.17', 'groupId': 'OG002', 'lowerLimit': '0.07', 'upperLimit': '1.50'}, {'value': '0.75', 'groupId': 'OG003', 'lowerLimit': '0.17', 'upperLimit': '2.02'}, {'value': '0.50', 'groupId': 'OG004', 'lowerLimit': '0.33', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During 12 hours after start of administration', 'description': 'The time at which maximum concentration is reached (Tmax)', 'unitOfMeasure': '(hours)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Rate Constant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nicotine 1', 'description': '1 administration of 1 mg'}, {'id': 'OG001', 'title': 'Oral Nicotine 2', 'description': '2 administrations of 1 mg'}, {'id': 'OG002', 'title': 'Oral Nicotine 4', 'description': '4 administrations of 1 mg'}, {'id': 'OG003', 'title': 'NiQuitinTM Lozenge 4 mg', 'description': '1 NiQuitinTM nicotine lozenge 4 mg'}, {'id': 'OG004', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '0.07', 'groupId': 'OG003'}, {'value': '0.31', 'spread': '0.10', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During 12 hours after start of administration', 'description': 'The terminal nicotine elimination rate constant (Lamda z)', 'unitOfMeasure': '(1/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Released Nicotine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '0.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': "After 30 minutes' chewing", 'description': "The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing", 'unitOfMeasure': '(ng/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Bioavailability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nicotine 1', 'description': '1 administration of 1 mg'}, {'id': 'OG001', 'title': 'Oral Nicotine 2', 'description': '2 administrations of 1 mg'}, {'id': 'OG002', 'title': 'Oral Nicotine 4', 'description': '4 administrations of 1 mg'}, {'id': 'OG003', 'title': 'NiQuitinTM Lozenge 4 mg', 'description': '1 NiQuitinTM nicotine lozenge 4 mg'}, {'id': 'OG004', 'title': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes'}], 'classes': [{'title': 'AUC to last measurable concentration', 'categories': [{'measurements': [{'value': '5.85', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '3.98', 'groupId': 'OG001'}, {'value': '21.96', 'spread': '9.00', 'groupId': 'OG002'}, {'value': '22.00', 'spread': '11.05', 'groupId': 'OG003'}, {'value': '19.69', 'spread': '7.95', 'groupId': 'OG004'}]}]}, {'title': 'AUC to infinity', 'categories': [{'measurements': [{'value': '7.54', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '13.30', 'spread': '4.20', 'groupId': 'OG001'}, {'value': '24.10', 'spread': '9.35', 'groupId': 'OG002'}, {'value': '24.30', 'spread': '11.91', 'groupId': 'OG003'}, {'value': '21.62', 'spread': '8.43', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '12 hours', 'description': "A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\\*nanograms/milliliter (h\\*ng/ml).", 'unitOfMeasure': 'h*ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Full Safety Set'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'NiQuitinTM Lozenge', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Nicorette® Gum', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Oral Nicotine 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Oral Nicotine 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Oral Nicotine 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Full Safety Set'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', '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': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2010-03-09', 'resultsFirstSubmitDate': '2010-04-16', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-10', 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration', 'timeFrame': 'During 12 hours after start of administration', 'description': 'Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)'}, {'measure': 'Bioavailability', 'timeFrame': '12 hours', 'description': "A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\\*nanograms/milliliter (h\\*ng/ml)."}], 'secondaryOutcomes': [{'measure': 'Nicotine Plasma Concentration', 'timeFrame': 'During 10 minutes after start of administration', 'description': 'Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)'}, {'measure': 'Time of Maximum Concentration', 'timeFrame': 'During 12 hours after start of administration', 'description': 'The time at which maximum concentration is reached (Tmax)'}, {'measure': 'Terminal Elimination Rate Constant', 'timeFrame': 'During 12 hours after start of administration', 'description': 'The terminal nicotine elimination rate constant (Lamda z)'}, {'measure': 'Released Nicotine', 'timeFrame': "After 30 minutes' chewing", 'description': "The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Nicotine pharmacokinetics'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.', 'detailedDescription': 'This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy smokers, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.\n* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.\n* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Pregnancy, lactation or intended pregnancy.\n* Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01084603', 'briefTitle': 'Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers', 'orgStudyIdInfo': {'id': 'NICTDP1065/A6431116'}, 'secondaryIdInfos': [{'id': '2008-006280-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Nicotine 1', 'description': 'One oral administration of 1 mg nicotine', 'interventionNames': ['Drug: Oral Nicotine']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Nicotine 2', 'description': 'Two oral administrations of 1 mg nicotine', 'interventionNames': ['Drug: Oral Nicotine']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Nicotine 4', 'description': 'Four oral administrations of 1 mg nicotine', 'interventionNames': ['Drug: Oral Nicotine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NiQuitinTM Nicotine Lozenge 4 mg', 'description': 'One 4 mg marketed nicotine lozenge', 'interventionNames': ['Drug: NiQuitinTM Nicotine Lozenge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicorette® Gum 4 mg', 'description': 'One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes', 'interventionNames': ['Drug: Nicorette® Nicotine Gum']}], 'interventions': [{'name': 'Oral Nicotine', 'type': 'DRUG', 'otherNames': ['Experimental nicotine 1 mg'], 'description': 'A new l mg oral nicotine product', 'armGroupLabels': ['Oral Nicotine 1', 'Oral Nicotine 2', 'Oral Nicotine 4']}, {'name': 'NiQuitinTM Nicotine Lozenge', 'type': 'DRUG', 'otherNames': ['NiQuitinTM lozenge'], 'description': 'A marketed 4 mg Nicotine lozenge', 'armGroupLabels': ['NiQuitinTM Nicotine Lozenge 4 mg']}, {'name': 'Nicorette® Nicotine Gum', 'type': 'DRUG', 'otherNames': ['Nicorette® gum'], 'description': 'A marketed 4 mg Nicotine Gum', 'armGroupLabels': ['Nicorette® Gum 4 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '222 20', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Clinical Pharmacology', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Elisabeth Kruse, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McNeil AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McNeil AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}