Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT05317195
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.PMI@pmi.com', 'phone': '+41 58 242 11 11', 'title': 'Christelle Haziza, Global Head Clinical Research and Execution', 'organization': 'Philip Morris Products S.A.'}, 'certainAgreement': {'otherDetails': "We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.\n\nThe Intellectual Property rights and research results from the present study belong to the Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 27 days.', 'description': 'Note that the "Safety Population (NP-1)" comprised 31 subjects who were enrolled in the study and performed a product test with NP-1 at admission. Following the product test, 24 subjects were randomized to product use.', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Population (NP-1 Test)', 'description': 'Comprised all enrolled subjects who, on Day -1, performed a product test using NP-1 for 30 minutes (± 1 minute).', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Safety Population (NP-1)', 'description': 'Comprised all enrolled subjects who were exposed to NP-1 during the study.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Safety Population (NP-2)', 'description': 'Comprised all enrolled subjects who were exposed to NP-2 during the study.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Safety Population (NP-3)', 'description': 'Comprised all enrolled subjects who were exposed to NP-3 during the study.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Safety Population (NP-4)', 'description': 'Comprised all enrolled subjects who were exposed to NP-4 during the study.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Safety Population (Velo-NP)', 'description': 'Comprised all enrolled subjects who were exposed to Velo-NP during the study.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Safety Population (Zyn-NP)', 'description': 'Comprised all enrolled subjects who were exposed to Zyn-NP during the study.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Background-corrected Maximum Plasma Concentration [Cmax]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'categories': [{'measurements': [{'value': '8.109', 'groupId': 'OG000', 'lowerLimit': '6.570', 'upperLimit': '9.649'}, {'value': '11.48', 'groupId': 'OG001', 'lowerLimit': '9.544', 'upperLimit': '13.42'}, {'value': '2.629', 'groupId': 'OG002', 'lowerLimit': '1.670', 'upperLimit': '3.588'}, {'value': '3.464', 'groupId': 'OG003', 'lowerLimit': '2.929', 'upperLimit': '3.999'}, {'value': '11.32', 'groupId': 'OG004', 'lowerLimit': '9.880', 'upperLimit': '12.75'}, {'value': '9.257', 'groupId': 'OG005', 'lowerLimit': '8.066', 'upperLimit': '10.45'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).', 'description': 'To measure the background-corrected maximum plasma concentration \\[Cmax\\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Background-corrected Time to the Maximum Concentration [Tmax]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'categories': [{'measurements': [{'value': '35.70', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '179'}, {'value': '34.80', 'groupId': 'OG001', 'lowerLimit': '9.96', 'upperLimit': '60.4'}, {'value': '34.89', 'groupId': 'OG002', 'lowerLimit': '9.72', 'upperLimit': '60.7'}, {'value': '34.98', 'groupId': 'OG003', 'lowerLimit': '29.8', 'upperLimit': '64.3'}, {'value': '33.99', 'groupId': 'OG004', 'lowerLimit': '9.72', 'upperLimit': '180'}, {'value': '34.95', 'groupId': 'OG005', 'lowerLimit': '22.9', 'upperLimit': '59.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).', 'description': 'To measure the background-corrected time to the maximum concentration \\[Tmax\\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'categories': [{'measurements': [{'value': '128.2', 'groupId': 'OG000', 'lowerLimit': '97.73', 'upperLimit': '158.6'}, {'value': '217.3', 'groupId': 'OG001', 'lowerLimit': '177.6', 'upperLimit': '256.9'}, {'value': '41.35', 'groupId': 'OG002', 'lowerLimit': '28.28', 'upperLimit': '54.42'}, {'value': '49.30', 'groupId': 'OG003', 'lowerLimit': '40.87', 'upperLimit': '57.73'}, {'value': '201.3', 'groupId': 'OG004', 'lowerLimit': '173.9', 'upperLimit': '228.7'}, {'value': '136.0', 'groupId': 'OG005', 'lowerLimit': '112.6', 'upperLimit': '159.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).', 'description': 'To measure the area under the background-corrected concentration-time curve (AUC) from start of product use of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.', 'unitOfMeasure': 'min*ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'title': 'Pre-Product Use', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '46.7', 'upperLimit': '75.2'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '49.6', 'upperLimit': '75.6'}, {'value': '64.3', 'groupId': 'OG002', 'lowerLimit': '51.4', 'upperLimit': '77.1'}, {'value': '67.4', 'groupId': 'OG003', 'lowerLimit': '55.0', 'upperLimit': '79.8'}, {'value': '68.6', 'groupId': 'OG004', 'lowerLimit': '56.8', 'upperLimit': '80.4'}, {'value': '68.9', 'groupId': 'OG005', 'lowerLimit': '54.9', 'upperLimit': '82.8'}]}]}, {'title': '5 min Post-Product Use', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '50.6'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '26.5', 'upperLimit': '49.7'}, {'value': '50.3', 'groupId': 'OG002', 'lowerLimit': '38.2', 'upperLimit': '62.5'}, {'value': '42.6', 'groupId': 'OG003', 'lowerLimit': '30.8', 'upperLimit': '54.4'}, {'value': '38.7', 'groupId': 'OG004', 'lowerLimit': '26.8', 'upperLimit': '50.7'}, {'value': '39.4', 'groupId': 'OG005', 'lowerLimit': '25.7', 'upperLimit': '53.1'}]}]}, {'title': '10 min Post-Product Use', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '49.7'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '45.5'}, {'value': '43.0', 'groupId': 'OG002', 'lowerLimit': '29.9', 'upperLimit': '56.1'}, {'value': '38.6', 'groupId': 'OG003', 'lowerLimit': '26.9', 'upperLimit': '50.3'}, {'value': '34.3', 'groupId': 'OG004', 'lowerLimit': '23.2', 'upperLimit': '45.5'}, {'value': '29.0', 'groupId': 'OG005', 'lowerLimit': '18.1', 'upperLimit': '40.0'}]}]}, {'title': '15 min Post-Product Use', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '37.7'}, {'value': '29.9', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '42.1'}, {'value': '39.5', 'groupId': 'OG002', 'lowerLimit': '26.4', 'upperLimit': '52.6'}, {'value': '36.5', 'groupId': 'OG003', 'lowerLimit': '23.8', 'upperLimit': '49.3'}, {'value': '31.7', 'groupId': 'OG004', 'lowerLimit': '21.1', 'upperLimit': '42.3'}, {'value': '26.9', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '37.9'}]}]}, {'title': '20 min Post-Product Use', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '39.9'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '44.3'}, {'value': '38.0', 'groupId': 'OG002', 'lowerLimit': '24.8', 'upperLimit': '51.2'}, {'value': '36.4', 'groupId': 'OG003', 'lowerLimit': '23.8', 'upperLimit': '48.9'}, {'value': '26.9', 'groupId': 'OG004', 'lowerLimit': '16.4', 'upperLimit': '37.3'}, {'value': '22.7', 'groupId': 'OG005', 'lowerLimit': '12.6', 'upperLimit': '32.8'}]}]}, {'title': '25 min Post-Product Use', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '40.1'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '39.8'}, {'value': '46.1', 'groupId': 'OG002', 'lowerLimit': '32.3', 'upperLimit': '59.9'}, {'value': '35.8', 'groupId': 'OG003', 'lowerLimit': '24.4', 'upperLimit': '47.3'}, {'value': '24.1', 'groupId': 'OG004', 'lowerLimit': '14.6', 'upperLimit': '33.5'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '11.8', 'upperLimit': '28.3'}]}]}, {'title': '30 min Post-Product Use', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '40.6'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': '39.5'}, {'value': '37.2', 'groupId': 'OG002', 'lowerLimit': '24.3', 'upperLimit': '50.0'}, {'value': '35.4', 'groupId': 'OG003', 'lowerLimit': '23.5', 'upperLimit': '47.3'}, {'value': '24.2', 'groupId': 'OG004', 'lowerLimit': '13.7', 'upperLimit': '34.8'}, {'value': '19.5', 'groupId': 'OG005', 'lowerLimit': '10.4', 'upperLimit': '28.7'}]}]}, {'title': '35 min Post-Product Use', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '38.1'}, {'value': '27.1', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '38.2'}, {'value': '36.9', 'groupId': 'OG002', 'lowerLimit': '23.5', 'upperLimit': '50.2'}, {'value': '33.7', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '46.4'}, {'value': '23.4', 'groupId': 'OG004', 'lowerLimit': '13.5', 'upperLimit': '33.2'}, {'value': '19.5', 'groupId': 'OG005', 'lowerLimit': '9.7', 'upperLimit': '29.3'}]}]}, {'title': '40 min Post-Product Use', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '40.9'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '40.7'}, {'value': '34.6', 'groupId': 'OG002', 'lowerLimit': '22.2', 'upperLimit': '46.9'}, {'value': '33.5', 'groupId': 'OG003', 'lowerLimit': '20.5', 'upperLimit': '46.5'}, {'value': '22.8', 'groupId': 'OG004', 'lowerLimit': '13.0', 'upperLimit': '32.6'}, {'value': '21.1', 'groupId': 'OG005', 'lowerLimit': '11.4', 'upperLimit': '30.9'}]}]}, {'title': '1 hr Post-Product Use', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '37.7'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '43.7'}, {'value': '44.9', 'groupId': 'OG002', 'lowerLimit': '31.4', 'upperLimit': '58.4'}, {'value': '35.8', 'groupId': 'OG003', 'lowerLimit': '23.6', 'upperLimit': '48.0'}, {'value': '24.3', 'groupId': 'OG004', 'lowerLimit': '14.4', 'upperLimit': '34.3'}, {'value': '24.7', 'groupId': 'OG005', 'lowerLimit': '14.5', 'upperLimit': '34.9'}]}]}, {'title': '3 hr Post-Product Use', 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': '60.3'}, {'value': '52.8', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '65.3'}, {'value': '53.9', 'groupId': 'OG002', 'lowerLimit': '41.5', 'upperLimit': '66.2'}, {'value': '51.5', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '64.7'}, {'value': '42.1', 'groupId': 'OG004', 'lowerLimit': '30.1', 'upperLimit': '54.2'}, {'value': '48.4', 'groupId': 'OG005', 'lowerLimit': '34.7', 'upperLimit': '62.0'}]}]}, {'title': '6 hr Post-Product Use', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '44.5', 'upperLimit': '72.1'}, {'value': '60.1', 'groupId': 'OG001', 'lowerLimit': '46.1', 'upperLimit': '74.1'}, {'value': '64.2', 'groupId': 'OG002', 'lowerLimit': '50.4', 'upperLimit': '77.9'}, {'value': '57.8', 'groupId': 'OG003', 'lowerLimit': '45.0', 'upperLimit': '70.6'}, {'value': '57.0', 'groupId': 'OG004', 'lowerLimit': '43.0', 'upperLimit': '70.9'}, {'value': '54.2', 'groupId': 'OG005', 'lowerLimit': '39.9', 'upperLimit': '68.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure cigarette craving by the visual analog scale (VAS)-craving assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Craving was assessed at selected time points on a scale from "no craving" (0 mm) to "strong craving" (100 mm) by measuring the number of millimeters (0-100 mm) from the "no craving" point to the point at which the drawn line intersected the scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of "in the Moment" Product Liking by the VAS-liking Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'title': '5 min Post-Product Use', 'categories': [{'measurements': [{'value': '49.7', 'groupId': 'OG000', 'lowerLimit': '39.6', 'upperLimit': '59.8'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '48.2', 'upperLimit': '63.5'}, {'value': '50.1', 'groupId': 'OG002', 'lowerLimit': '41.0', 'upperLimit': '59.2'}, {'value': '48.2', 'groupId': 'OG003', 'lowerLimit': '39.3', 'upperLimit': '57.1'}, {'value': '51.7', 'groupId': 'OG004', 'lowerLimit': '44.3', 'upperLimit': '59.1'}, {'value': '60.2', 'groupId': 'OG005', 'lowerLimit': '51.9', 'upperLimit': '68.5'}]}]}, {'title': '10 min Post-Product Use', 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '43.7', 'upperLimit': '65.8'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '66.7'}, {'value': '52.1', 'groupId': 'OG002', 'lowerLimit': '42.8', 'upperLimit': '61.4'}, {'value': '52.1', 'groupId': 'OG003', 'lowerLimit': '42.8', 'upperLimit': '61.5'}, {'value': '55.8', 'groupId': 'OG004', 'lowerLimit': '47.1', 'upperLimit': '64.5'}, {'value': '60.6', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '71.2'}]}]}, {'title': '15 min Post-Product Use', 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '69.5'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '45.5', 'upperLimit': '68.9'}, {'value': '52.4', 'groupId': 'OG002', 'lowerLimit': '41.7', 'upperLimit': '63.1'}, {'value': '52.7', 'groupId': 'OG003', 'lowerLimit': '43.9', 'upperLimit': '61.5'}, {'value': '56.1', 'groupId': 'OG004', 'lowerLimit': '46.7', 'upperLimit': '65.5'}, {'value': '58.7', 'groupId': 'OG005', 'lowerLimit': '47.2', 'upperLimit': '70.3'}]}]}, {'title': '20 min Post-Product Use', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '63.2'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '66.0'}, {'value': '52.1', 'groupId': 'OG002', 'lowerLimit': '41.4', 'upperLimit': '62.8'}, {'value': '54.5', 'groupId': 'OG003', 'lowerLimit': '45.4', 'upperLimit': '63.7'}, {'value': '58.7', 'groupId': 'OG004', 'lowerLimit': '47.1', 'upperLimit': '70.3'}, {'value': '60.3', 'groupId': 'OG005', 'lowerLimit': '47.7', 'upperLimit': '72.9'}]}]}, {'title': '25 min Post-Product Use', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '66.8'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '42.4', 'upperLimit': '65.7'}, {'value': '51.4', 'groupId': 'OG002', 'lowerLimit': '39.7', 'upperLimit': '63.1'}, {'value': '52.7', 'groupId': 'OG003', 'lowerLimit': '43.3', 'upperLimit': '62.2'}, {'value': '54.7', 'groupId': 'OG004', 'lowerLimit': '41.0', 'upperLimit': '68.4'}, {'value': '61.6', 'groupId': 'OG005', 'lowerLimit': '49.7', 'upperLimit': '73.5'}]}]}, {'title': '30 min Post-Product Use', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '48.1', 'upperLimit': '71.8'}, {'value': '53.5', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '66.5'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '41.5', 'upperLimit': '62.6'}, {'value': '51.7', 'groupId': 'OG003', 'lowerLimit': '41.1', 'upperLimit': '62.3'}, {'value': '57.7', 'groupId': 'OG004', 'lowerLimit': '44.8', 'upperLimit': '70.7'}, {'value': '59.9', 'groupId': 'OG005', 'lowerLimit': '47.5', 'upperLimit': '72.3'}]}]}, {'title': '35 min Post-Product Use', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '67.8'}, {'value': '56.5', 'groupId': 'OG001', 'lowerLimit': '44.9', 'upperLimit': '68.1'}, {'value': '51.4', 'groupId': 'OG002', 'lowerLimit': '40.4', 'upperLimit': '62.3'}, {'value': '54.0', 'groupId': 'OG003', 'lowerLimit': '43.8', 'upperLimit': '64.2'}, {'value': '57.0', 'groupId': 'OG004', 'lowerLimit': '44.4', 'upperLimit': '69.6'}, {'value': '59.4', 'groupId': 'OG005', 'lowerLimit': '45.6', 'upperLimit': '73.2'}]}]}, {'title': '40 min Post-Product Use', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '69.4'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '66.4'}, {'value': '51.4', 'groupId': 'OG002', 'lowerLimit': '40.3', 'upperLimit': '62.6'}, {'value': '53.6', 'groupId': 'OG003', 'lowerLimit': '43.0', 'upperLimit': '64.3'}, {'value': '57.2', 'groupId': 'OG004', 'lowerLimit': '45.2', 'upperLimit': '69.3'}, {'value': '58.7', 'groupId': 'OG005', 'lowerLimit': '45.7', 'upperLimit': '71.7'}]}]}, {'title': '1 hr Post-Product Use', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000', 'lowerLimit': '41.8', 'upperLimit': '67.6'}, {'value': '54.5', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '65.9'}, {'value': '49.8', 'groupId': 'OG002', 'lowerLimit': '39.1', 'upperLimit': '60.4'}, {'value': '53.4', 'groupId': 'OG003', 'lowerLimit': '43.5', 'upperLimit': '63.2'}, {'value': '55.6', 'groupId': 'OG004', 'lowerLimit': '43.7', 'upperLimit': '67.6'}, {'value': '58.2', 'groupId': 'OG005', 'lowerLimit': '45.9', 'upperLimit': '70.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure "in the moment" product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Overall Product Liking by the VAS-liking Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '46.8', 'upperLimit': '66.3'}, {'value': '53.2', 'groupId': 'OG001', 'lowerLimit': '44.6', 'upperLimit': '61.8'}, {'value': '49.0', 'groupId': 'OG002', 'lowerLimit': '40.1', 'upperLimit': '57.9'}, {'value': '49.5', 'groupId': 'OG003', 'lowerLimit': '40.2', 'upperLimit': '58.9'}, {'value': '49.9', 'groupId': 'OG004', 'lowerLimit': '39.3', 'upperLimit': '60.5'}, {'value': '52.3', 'groupId': 'OG005', 'lowerLimit': '40.7', 'upperLimit': '64.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure overall product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Overall product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Product Satisfaction by the VAS-satisfaction Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'title': '5 min Post-Product Use', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '62.6'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '62.0'}, {'value': '45.8', 'groupId': 'OG002', 'lowerLimit': '35.8', 'upperLimit': '55.8'}, {'value': '50.2', 'groupId': 'OG003', 'lowerLimit': '41.2', 'upperLimit': '59.2'}, {'value': '48.4', 'groupId': 'OG004', 'lowerLimit': '39.9', 'upperLimit': '56.9'}, {'value': '55.8', 'groupId': 'OG005', 'lowerLimit': '45.2', 'upperLimit': '66.3'}]}]}, {'title': '10 min Post-Product Use', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '69.3'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '68.4'}, {'value': '48.2', 'groupId': 'OG002', 'lowerLimit': '37.4', 'upperLimit': '59.1'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '39.9', 'upperLimit': '60.2'}, {'value': '54.5', 'groupId': 'OG004', 'lowerLimit': '45.1', 'upperLimit': '63.8'}, {'value': '62.0', 'groupId': 'OG005', 'lowerLimit': '52.0', 'upperLimit': '72.1'}]}]}, {'title': '15 min Post-Product Use', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '50.9', 'upperLimit': '70.8'}, {'value': '57.9', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '69.5'}, {'value': '50.5', 'groupId': 'OG002', 'lowerLimit': '40.3', 'upperLimit': '60.8'}, {'value': '49.5', 'groupId': 'OG003', 'lowerLimit': '39.4', 'upperLimit': '59.5'}, {'value': '57.5', 'groupId': 'OG004', 'lowerLimit': '48.4', 'upperLimit': '66.7'}, {'value': '62.4', 'groupId': 'OG005', 'lowerLimit': '50.1', 'upperLimit': '74.7'}]}]}, {'title': '20 min Post-Product Use', 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '71.9'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '65.8'}, {'value': '49.7', 'groupId': 'OG002', 'lowerLimit': '39.0', 'upperLimit': '60.4'}, {'value': '49.3', 'groupId': 'OG003', 'lowerLimit': '38.5', 'upperLimit': '60.1'}, {'value': '61.0', 'groupId': 'OG004', 'lowerLimit': '49.4', 'upperLimit': '72.6'}, {'value': '65.2', 'groupId': 'OG005', 'lowerLimit': '53.3', 'upperLimit': '77.1'}]}]}, {'title': '25 min Post-Product Use', 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '67.1'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '67.7'}, {'value': '50.1', 'groupId': 'OG002', 'lowerLimit': '38.8', 'upperLimit': '61.4'}, {'value': '50.8', 'groupId': 'OG003', 'lowerLimit': '39.8', 'upperLimit': '61.7'}, {'value': '58.2', 'groupId': 'OG004', 'lowerLimit': '45.7', 'upperLimit': '70.6'}, {'value': '67.5', 'groupId': 'OG005', 'lowerLimit': '55.7', 'upperLimit': '79.2'}]}]}, {'title': '30 min Post-Product Use', 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '73.6'}, {'value': '58.2', 'groupId': 'OG001', 'lowerLimit': '46.8', 'upperLimit': '69.7'}, {'value': '50.4', 'groupId': 'OG002', 'lowerLimit': '39.4', 'upperLimit': '61.4'}, {'value': '50.2', 'groupId': 'OG003', 'lowerLimit': '38.4', 'upperLimit': '62.0'}, {'value': '61.6', 'groupId': 'OG004', 'lowerLimit': '49.2', 'upperLimit': '74.0'}, {'value': '67.3', 'groupId': 'OG005', 'lowerLimit': '54.8', 'upperLimit': '79.8'}]}]}, {'title': '35 min Post-Product Use', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000', 'lowerLimit': '49.9', 'upperLimit': '72.5'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '67.9'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '34.6', 'upperLimit': '57.5'}, {'value': '52.9', 'groupId': 'OG003', 'lowerLimit': '41.4', 'upperLimit': '64.4'}, {'value': '60.4', 'groupId': 'OG004', 'lowerLimit': '48.4', 'upperLimit': '72.4'}, {'value': '65.1', 'groupId': 'OG005', 'lowerLimit': '53.4', 'upperLimit': '76.9'}]}]}, {'title': '40 min Post-Product Use', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '45.9', 'upperLimit': '72.2'}, {'value': '53.2', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '66.3'}, {'value': '44.4', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '57.0'}, {'value': '51.7', 'groupId': 'OG003', 'lowerLimit': '39.4', 'upperLimit': '63.9'}, {'value': '61.4', 'groupId': 'OG004', 'lowerLimit': '51.0', 'upperLimit': '71.8'}, {'value': '60.5', 'groupId': 'OG005', 'lowerLimit': '47.8', 'upperLimit': '73.1'}]}]}, {'title': '1 hr Post-Product Use', 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000', 'lowerLimit': '40.5', 'upperLimit': '67.8'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '65.0'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '31.5', 'upperLimit': '55.6'}, {'value': '50.3', 'groupId': 'OG003', 'lowerLimit': '38.9', 'upperLimit': '61.8'}, {'value': '57.9', 'groupId': 'OG004', 'lowerLimit': '46.4', 'upperLimit': '69.4'}, {'value': '59.5', 'groupId': 'OG005', 'lowerLimit': '47.4', 'upperLimit': '71.5'}]}]}, {'title': '3 hr Post-Product Use', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '34.5', 'upperLimit': '58.0'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '47.4'}, {'value': '36.9', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '47.5'}, {'value': '37.3', 'groupId': 'OG003', 'lowerLimit': '27.1', 'upperLimit': '47.6'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '33.2', 'upperLimit': '55.5'}, {'value': '38.1', 'groupId': 'OG005', 'lowerLimit': '25.0', 'upperLimit': '51.3'}]}]}, {'title': '6 hr Post-Product Use', 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '44.2'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '38.0'}, {'value': '33.6', 'groupId': 'OG002', 'lowerLimit': '23.0', 'upperLimit': '44.2'}, {'value': '33.2', 'groupId': 'OG003', 'lowerLimit': '23.3', 'upperLimit': '43.1'}, {'value': '29.2', 'groupId': 'OG004', 'lowerLimit': '19.7', 'upperLimit': '38.7'}, {'value': '35.4', 'groupId': 'OG005', 'lowerLimit': '23.0', 'upperLimit': '47.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure product satisfaction by the VAS-satisfaction assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product satisfaction was was assessed at selected time points on a scale from "not at all" (0 mm) to "extremely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "not at all" point to the point at which the drawn line intersected the scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)\n\nNP-1: NP-1; 8.4 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG001', 'title': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)\n\nNP-2: NP-2; 8.4 mg nicotine; pH 9.0; moisture 30'}, {'id': 'OG002', 'title': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)\n\nNP-3: NP-3; 3.6 mg nicotine; pH 8.0; moisture 15'}, {'id': 'OG003', 'title': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)\n\nNP-4: NP-4; 3.6 mg nicotine; pH 8.0; moisture 30'}, {'id': 'OG004', 'title': 'Velo-NP', 'description': 'Velo® Ice Cool\n\nVelo-NP: Velo-NP; 10 mg nicotine;'}, {'id': 'OG005', 'title': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry\n\nZyn-NP: Zyn-NP; 3 mg nicotine;'}], 'classes': [{'title': '30 min Post-Product Use', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '64.9'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '38.8', 'upperLimit': '65.1'}, {'value': '46.7', 'groupId': 'OG002', 'lowerLimit': '35.1', 'upperLimit': '58.2'}, {'value': '48.3', 'groupId': 'OG003', 'lowerLimit': '36.2', 'upperLimit': '60.3'}, {'value': '55.3', 'groupId': 'OG004', 'lowerLimit': '42.9', 'upperLimit': '67.6'}, {'value': '57.9', 'groupId': 'OG005', 'lowerLimit': '43.2', 'upperLimit': '72.6'}]}]}, {'title': '3 hr Post-Product Use', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '61.9'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '37.8', 'upperLimit': '58.4'}, {'value': '51.6', 'groupId': 'OG002', 'lowerLimit': '42.5', 'upperLimit': '60.6'}, {'value': '44.5', 'groupId': 'OG003', 'lowerLimit': '33.0', 'upperLimit': '55.9'}, {'value': '50.9', 'groupId': 'OG004', 'lowerLimit': '39.5', 'upperLimit': '62.2'}, {'value': '49.5', 'groupId': 'OG005', 'lowerLimit': '35.3', 'upperLimit': '63.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure intention to use product again by the VAS-intention to use again assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Intention to use again was was assessed at selected time points on a scale from "very unlikely" (0 mm) to "very likely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "very unlikely" point to the point at which the drawn line intersected the scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All study participants.'}], 'periods': [{'title': 'Product Test (Enrolled Subjects)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}, {'title': 'Admission', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Product Use (Randomized Subjects)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NP-1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NP-2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NP-3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NP-4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Velo-NP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Zyn-NP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '31 subjects were enrolled in the study, which was conducted at a clinical trial facility managed by a contract research organization.', 'preAssignmentDetails': 'Of the 31 enrolled subjects who performed a product test, 24 were randomized to product use. Seven of the 31 enrolled subjects were not randomized because only 24 subjects were required for the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Population', 'description': 'The safety population was a subset of the screened population and comprised all the subjects who signed ICF consent and had at least one exposure to NP 1.0 (including the product test with NP-1 at Admission).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '9.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fagerström score', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Fagerström Test for Nicotine Dependence is a standard instrument for assessing nicotine dependence. Subjects respond to six items in a questionnaire to obtain a total score between 0 and 10. Higher scores indicate an increased level of nicotine dependence.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-07', 'size': 1057287, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-05T09:17', 'hasProtocol': True}, {'date': '2022-03-21', 'size': 730502, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-05T09:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2022-03-30', 'resultsFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-24', 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Background-corrected Maximum Plasma Concentration [Cmax]', 'timeFrame': 'T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).', 'description': 'To measure the background-corrected maximum plasma concentration \\[Cmax\\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.'}, {'measure': 'Background-corrected Time to the Maximum Concentration [Tmax]', 'timeFrame': 'T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).', 'description': 'To measure the background-corrected time to the maximum concentration \\[Tmax\\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.'}, {'measure': 'Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)', 'timeFrame': 'T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).', 'description': 'To measure the area under the background-corrected concentration-time curve (AUC) from start of product use of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.'}], 'secondaryOutcomes': [{'measure': 'Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment', 'timeFrame': 'Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure cigarette craving by the visual analog scale (VAS)-craving assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Craving was assessed at selected time points on a scale from "no craving" (0 mm) to "strong craving" (100 mm) by measuring the number of millimeters (0-100 mm) from the "no craving" point to the point at which the drawn line intersected the scale.'}, {'measure': 'Score of "in the Moment" Product Liking by the VAS-liking Assessment', 'timeFrame': 'Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure "in the moment" product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.'}, {'measure': 'Score of Overall Product Liking by the VAS-liking Assessment', 'timeFrame': 'Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure overall product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Overall product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.'}, {'measure': 'Score of Product Satisfaction by the VAS-satisfaction Assessment', 'timeFrame': 'Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure product satisfaction by the VAS-satisfaction assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product satisfaction was was assessed at selected time points on a scale from "not at all" (0 mm) to "extremely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "not at all" point to the point at which the drawn line intersected the scale.'}, {'measure': 'Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment', 'timeFrame': 'Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)', 'description': 'To measure intention to use product again by the VAS-intention to use again assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Intention to use again was was assessed at selected time points on a scale from "very unlikely" (0 mm) to "very likely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "very unlikely" point to the point at which the drawn line intersected the scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nicotine-containing products', 'Nicotine delivery'], 'conditions': ['Smoking', 'Nicotine']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over).', 'detailedDescription': 'Study Title:\n\nNicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers\n\nWho carried out the research? This research was sponsored and funded by Philip Morris Products S.A.\n\nWhat public involvement there was in the study? The study recruited 31 healthy adults who were currently smoking.\n\nWhere and when the study took place The study was conducted at a clinical trial facility managed by a contract research organization in Belfast, Northern Ireland, from March 15th to August 18th 2022.\n\nWhy was the research needed? The research was needed to understand the pharmacokinetic profiles of four variants of a nicotine pouch.\n\nWhat were the main questions studied? The study measured the nicotine absorption of the four variants of nicotine pouch (NP-1; NP-2; NP-3; NP-4) together with two nicotine pouches marketed by other companies (Zyn-NP and Velo-NP). Participants were also asked to evaluate their experience of using the nicotine pouches.\n\nWho participated in the study? The study recruited 31 healthy, male or female, adults aged between 21 and 65 years who were currently smoking. The subjects did not plan to quit using tobacco and/or nicotine products within the next 3 months and had smoked continuously for at least the last 3 years prior to joining the study..\n\nEach subject was given full and adequate oral and written information about the nature, purpose, possible risks and benefits of the study. Once each subject had received all the necessary information, and if he/she agreed to participate, this was documented in an Informed Consent Form with the date, time and signature of both the subject and the Investigator.\n\nSubjects were informed that they were free to withdraw from the study at any time.\n\nWhat treatments or interventions did the participants take/receive? The participants were requested to use a tobacco-free nicotine pouch for a period of 30 minutes. Blood samples were taken before, during, and after the product use period.\n\nParticipants were also asked to evaluate their experience of using the nicotine pouches, using the Product Evaluation Scale (PES).\n\nThe PES is composed of seven items which address the degree to which subjects experience seven different effects (Product Satisfaction, Psychological Rewards, Aversion, Craving Relief, Easy to Use, Comfortable Using, Concerned about Dependence) as a result of using the investigational products, rated on a 7 point scale from 1 = "not at all" to 7 = "extremely."\n\nWhat happened during the study? The study was conducted with six periods and six sequences in a cross-over design. On Day -1, subjects were randomized to one of the six study sequences.\n\nAfter enrollment, subjects performed a product test with Nicotine Pouch 1.0 (NP-1) for 30 minutes (± 1 minute). One NP-1 nicotine pouch was placed between the upper lip and the gum for 30 minutes and subjects were instructed not to manipulate the pouch with the tongue or lips.\n\nAfter the product test, subjects were required to abstain from any nicotine/tobacco-containing product use until the first product use on Day 1.\n\nOn Day 1 to Day 3, after at least 8 hours of abstinence from any nicotine/tobacco-containing products (nicotine wash-out), subjects used one variant of NP 1.0, Velo-NP, or Zyn-NP according to the randomized product use sequence for 30 minutes (± 1 minute). The used NP were collected for long-term storage to determine the residual nicotine after product use to estimate the amount of nicotine delivered during the 30-minute use period.\n\nSubjects completed questionnaires about product evaluation, craving, and liking assessments.\n\nIn the morning on Day 1, 12 blood samples were collected for determination of nicotine concentration. Additional blood samples were taken for determination of the nicotine concentration on Day 2 and Day 3.\n\nAfter Discharge at Day 3, the subjects entered a 3-day Safety Follow-Up period during which adverse reactions associated with product use reported by the subjects were collected and the follow-up of any ongoing adverse reactions was conducted by the study investigational site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Subject has smoked continuously for at least the last 3 years prior to the Screening visit.\n* Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 500 ng/mL).\n* Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months.\n* Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.\n\nMain Exclusion Criteria:\n\n* As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.\n* Subject is legally incompetent, or physically or mentally incapable of giving consent.\n* Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject.\n* Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.\n* Subject has a BMI \\< 18.5 kg/m2 or \\> 32.0 kg/m2 (Europe) or \\> 35.0 kg/m2 (USA).\n* For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding."}, 'identificationModule': {'nctId': 'NCT05317195', 'briefTitle': 'Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philip Morris Products S.A.'}, 'officialTitle': 'A Single-center, Randomized, Controlled, Open-label Study to Investigate the Nicotine Pharmacokinetic Profiles and Subjective Effects of Four Variants of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers', 'orgStudyIdInfo': {'id': 'P5-PK-01-EXP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NP-1', 'description': 'Nicotine Pouch 1.0 (variant NP-1)', 'interventionNames': ['Other: NP-1', 'Other: NP-2', 'Other: NP-3', 'Other: NP-4', 'Other: Velo-NP', 'Other: Zyn-NP']}, {'type': 'EXPERIMENTAL', 'label': 'NP-2', 'description': 'Nicotine Pouch 1.0 (variant NP-2)', 'interventionNames': ['Other: NP-1', 'Other: NP-2', 'Other: NP-3', 'Other: NP-4', 'Other: Velo-NP', 'Other: Zyn-NP']}, {'type': 'EXPERIMENTAL', 'label': 'NP-3', 'description': 'Nicotine Pouch 1.0 (variant NP-3)', 'interventionNames': ['Other: NP-1', 'Other: NP-2', 'Other: NP-3', 'Other: NP-4', 'Other: Velo-NP', 'Other: Zyn-NP']}, {'type': 'EXPERIMENTAL', 'label': 'NP-4', 'description': 'Nicotine Pouch 1.0 (variant NP-4)', 'interventionNames': ['Other: NP-1', 'Other: NP-2', 'Other: NP-3', 'Other: NP-4', 'Other: Velo-NP', 'Other: Zyn-NP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Velo-NP', 'description': 'Velo® Ice Cool', 'interventionNames': ['Other: NP-1', 'Other: NP-2', 'Other: NP-3', 'Other: NP-4', 'Other: Velo-NP', 'Other: Zyn-NP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zyn-NP', 'description': 'Zyn® Cool Mint Mini Dry', 'interventionNames': ['Other: NP-1', 'Other: NP-2', 'Other: NP-3', 'Other: NP-4', 'Other: Velo-NP', 'Other: Zyn-NP']}], 'interventions': [{'name': 'NP-1', 'type': 'OTHER', 'description': 'NP-1; 8.4 mg nicotine; pH 8.0; moisture 30', 'armGroupLabels': ['NP-1', 'NP-2', 'NP-3', 'NP-4', 'Velo-NP', 'Zyn-NP']}, {'name': 'NP-2', 'type': 'OTHER', 'description': 'NP-2; 8.4 mg nicotine; pH 9.0; moisture 30', 'armGroupLabels': ['NP-1', 'NP-2', 'NP-3', 'NP-4', 'Velo-NP', 'Zyn-NP']}, {'name': 'NP-3', 'type': 'OTHER', 'description': 'NP-3; 3.6 mg nicotine; pH 8.0; moisture 15', 'armGroupLabels': ['NP-1', 'NP-2', 'NP-3', 'NP-4', 'Velo-NP', 'Zyn-NP']}, {'name': 'NP-4', 'type': 'OTHER', 'description': 'NP-4; 3.6 mg nicotine; pH 8.0; moisture 30', 'armGroupLabels': ['NP-1', 'NP-2', 'NP-3', 'NP-4', 'Velo-NP', 'Zyn-NP']}, {'name': 'Velo-NP', 'type': 'OTHER', 'description': 'Velo-NP; 10 mg nicotine;', 'armGroupLabels': ['NP-1', 'NP-2', 'NP-3', 'NP-4', 'Velo-NP', 'Zyn-NP']}, {'name': 'Zyn-NP', 'type': 'OTHER', 'description': 'Zyn-NP; 3 mg nicotine;', 'armGroupLabels': ['NP-1', 'NP-2', 'NP-3', 'NP-4', 'Velo-NP', 'Zyn-NP']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 6AD', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Celerion', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Rajkumar Chetty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celerion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philip Morris Products S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}