Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-07 @ 7:44 PM
Study NCT ID:
NCT02465866
Status:
COMPLETED
Last Update Posted:
2017-05-02
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C409362', 'term': 'hydrocodone tartrate, ibuprofen drug combination'}, {'id': 'C478659', 'term': 'Ultracet'}, {'id': 'D011398', 'term': 'Promethazine'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cliregulatory@charlestonlabs.com', 'phone': '561-748-2007', 'title': 'Chief Commercial Officer', 'organization': 'Charleston Laboratories, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to day 72', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition', 'otherNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition', 'otherNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition', 'otherNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '20.0', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '5.80', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '5.62', 'groupId': 'OG002'}, {'value': '17.5', 'spread': '3.63', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '4.71', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '5.02', 'spread': '1.66', 'groupId': 'OG002'}, {'value': '3.03', 'spread': '0.919', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '4.79', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '4.35', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '4.08', 'spread': '1.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intended to treat (ITT) population'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '3.09', 'spread': '1.89', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '2.84', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.55', 'groupId': 'OG002'}, {'value': '2.64', 'spread': '1.44', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '4.35', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '4.90', 'spread': '1.72', 'groupId': 'OG002'}, {'value': '6.45', 'spread': '4.59', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '0.556', 'spread': '0.354', 'groupId': 'OG000'}, {'value': '0.523', 'spread': '0.412', 'groupId': 'OG001'}, {'value': '0.465', 'spread': '0.315', 'groupId': 'OG002'}, {'value': '0.527', 'spread': '0.424', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '0.0741', 'spread': '0.0297', 'groupId': 'OG000'}, {'value': '0.0917', 'spread': '0.0378', 'groupId': 'OG001'}, {'value': '0.0724', 'spread': '0.0291', 'groupId': 'OG002'}, {'value': '0.0907', 'spread': '0.0428', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '0.611', 'spread': '0.936', 'groupId': 'OG000'}, {'value': '0.586', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '0.574', 'spread': '0.829', 'groupId': 'OG002'}, {'value': '0.701', 'spread': '0.912', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Time of the Last Quantifiable Concentration (Tlast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '27.80', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '31.21', 'spread': '11.28', 'groupId': 'OG001'}, {'value': '28.81', 'spread': '9.84', 'groupId': 'OG002'}, {'value': '31.58', 'spread': '11.46', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '23.38', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '24.01', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '23.41', 'spread': '2.69', 'groupId': 'OG002'}, {'value': '24.01', 'spread': '0.02', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '46.76', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '46.77', 'spread': '5.52', 'groupId': 'OG001'}, {'value': '46.81', 'spread': '5.37', 'groupId': 'OG002'}, {'value': '46.74', 'spread': '5.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Observed Elimination Rate Constant (λz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '0.1468', 'spread': '0.0293', 'groupId': 'OG000'}, {'value': '0.1373', 'spread': '0.0258', 'groupId': 'OG001'}, {'value': '0.1415', 'spread': '0.0292', 'groupId': 'OG002'}, {'value': '0.1371', 'spread': '0.0271', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '0.1577', 'spread': '0.0310', 'groupId': 'OG000'}, {'value': '0.1359', 'spread': '0.0223', 'groupId': 'OG001'}, {'value': '0.1600', 'spread': '0.0355', 'groupId': 'OG002'}, {'value': '0.1412', 'spread': '0.0218', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,18,20,18)', 'categories': [{'measurements': [{'value': '0.0429', 'spread': '0.0129', 'groupId': 'OG000'}, {'value': '0.0451', 'spread': '0.0451', 'groupId': 'OG001'}, {'value': '0.0422', 'spread': '0.0120', 'groupId': 'OG002'}, {'value': '0.0458', 'spread': '0.0145', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile', 'unitOfMeasure': 'h-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Observed Terminal Elimination Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '4.93', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '5.13', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '5.26', 'spread': '1.08', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '4.59', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '4.52', 'spread': '0.93', 'groupId': 'OG002'}, {'value': '5.03', 'spread': '0.86', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,18,20,18)', 'categories': [{'measurements': [{'value': '17.49', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '15.95', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '17.77', 'spread': '5.57', 'groupId': 'OG002'}, {'value': '16.24', 'spread': '4.09', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated as: T1/2 = ln(2)/λz', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '0.08870', 'spread': '0.1318', 'groupId': 'OG000'}, {'value': '0.03786', 'spread': '0.1269', 'groupId': 'OG001'}, {'value': '0.1219', 'spread': '0.2151', 'groupId': 'OG002'}, {'value': '0.02250', 'spread': '0.04577', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '0.01086', 'spread': '0.03169', 'groupId': 'OG000'}, {'value': '0.003941', 'spread': '0.01413', 'groupId': 'OG001'}, {'value': '0.006288', 'spread': '0.02608', 'groupId': 'OG002'}, {'value': '0.002612', 'spread': '0.01138', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose) to 0.25 hours post-dose', 'description': 'AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'AUC0-0.50 for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '0.9532', 'spread': '0.9498', 'groupId': 'OG000'}, {'value': '0.2566', 'spread': '0.6382', 'groupId': 'OG001'}, {'value': '1.280', 'spread': '1.271', 'groupId': 'OG002'}, {'value': '0.3163', 'spread': '0.4305', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '0.03535', 'spread': '0.06239', 'groupId': 'OG000'}, {'value': '0.01570', 'spread': '0.03508', 'groupId': 'OG001'}, {'value': '0.02692', 'spread': '0.06096', 'groupId': 'OG002'}, {'value': '0.01220', 'spread': '0.02452', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose) to 0.5 hours post-dose', 'description': 'AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'AUC0-0.75 for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '3.194', 'spread': '2.379', 'groupId': 'OG000'}, {'value': '0.8759', 'spread': '1.645', 'groupId': 'OG001'}, {'value': '4.027', 'spread': '3.092', 'groupId': 'OG002'}, {'value': '1.276', 'spread': '1.629', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '0.1108', 'spread': '0.1090', 'groupId': 'OG000'}, {'value': '0.05549', 'spread': '0.08128', 'groupId': 'OG001'}, {'value': '0.09690', 'spread': '0.1478', 'groupId': 'OG002'}, {'value': '0.04610', 'spread': '0.06227', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (Pre-dose) to 0.75 hours post-dose', 'description': 'AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'AUC0-1.0 for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '6.383', 'spread': '3.637', 'groupId': 'OG000'}, {'value': '2.046', 'spread': '3.244', 'groupId': 'OG001'}, {'value': '7.524', 'spread': '4.678', 'groupId': 'OG002'}, {'value': '2.722', 'spread': '3.329', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '0.2578', 'spread': '0.1999', 'groupId': 'OG000'}, {'value': '0.1457', 'spread': '0.1649', 'groupId': 'OG001'}, {'value': '0.2311', 'spread': '0.3055', 'groupId': 'OG002'}, {'value': '0.1109', 'spread': '0.1471', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose) to 1.0 hours post-dose', 'description': 'AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'AUC0-1.5 for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '14.33', 'spread': '4.971', 'groupId': 'OG000'}, {'value': '5.782', 'spread': '7.049', 'groupId': 'OG001'}, {'value': '14.95', 'spread': '6.822', 'groupId': 'OG002'}, {'value': '6.424', 'spread': '6.742', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '0.8524', 'spread': '0.5410', 'groupId': 'OG000'}, {'value': '0.5573', 'spread': '0.4798', 'groupId': 'OG001'}, {'value': '0.7330', 'spread': '0.8395', 'groupId': 'OG002'}, {'value': '0.3239', 'spread': '0.3643', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose) to 1.5 hours post-dose', 'description': 'AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'AUC0-2.0 for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '23.21', 'spread': '6.240', 'groupId': 'OG000'}, {'value': '10.95', 'spread': '10.34', 'groupId': 'OG001'}, {'value': '22.53', 'spread': '8.183', 'groupId': 'OG002'}, {'value': '11.04', 'spread': '10.12', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '1.938', 'spread': '1.318', 'groupId': 'OG000'}, {'value': '1.267', 'spread': '0.9936', 'groupId': 'OG001'}, {'value': '1.583', 'spread': '1.689', 'groupId': 'OG002'}, {'value': '0.6735', 'spread': '0.6328', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose) to 2 hours post-dose', 'description': 'AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'AUC0-4.0 for Hydrocodone and Promethazine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '54.04', 'spread': '13.77', 'groupId': 'OG000'}, {'value': '38.97', 'spread': '18.47', 'groupId': 'OG001'}, {'value': '48.35', 'spread': '12.87', 'groupId': 'OG002'}, {'value': '35.14', 'spread': '17.97', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '9.124', 'spread': '6.271', 'groupId': 'OG000'}, {'value': '5.943', 'spread': '3.676', 'groupId': 'OG001'}, {'value': '7.101', 'spread': '6.159', 'groupId': 'OG002'}, {'value': '4.045', 'spread': '2.497', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose) to 4 hours post-dose', 'description': 'AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '146.2', 'spread': '56.77', 'groupId': 'OG000'}, {'value': '151.9', 'spread': '58.79', 'groupId': 'OG001'}, {'value': '130.9', 'spread': '47.94', 'groupId': 'OG002'}, {'value': '148.5', 'spread': '56.84', 'groupId': 'OG003'}]}]}, {'title': 'Acetaminophen', 'categories': [{'measurements': [{'value': '19.19', 'spread': '5.661', 'groupId': 'OG000'}, {'value': '17.85', 'spread': '4.621', 'groupId': 'OG001'}, {'value': '18.69', 'spread': '5.186', 'groupId': 'OG002'}, {'value': '17.85', 'spread': '4.742', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,19,20,19)', 'categories': [{'measurements': [{'value': '75.69', 'spread': '78.87', 'groupId': 'OG000'}, {'value': '66.63', 'spread': '67.37', 'groupId': 'OG001'}, {'value': '68.54', 'spread': '63.24', 'groupId': 'OG002'}, {'value': '74.76', 'spread': '57.53', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated using the linear trapezoidal rule', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '150.2', 'spread': '57.30', 'groupId': 'OG000'}, {'value': '155.8', 'spread': '58.75', 'groupId': 'OG001'}, {'value': '134.3', 'spread': '48.20', 'groupId': 'OG002'}, {'value': '152.4', 'spread': '56.83', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,18,20,18)', 'categories': [{'measurements': [{'value': '96.92', 'spread': '119.5', 'groupId': 'OG000'}, {'value': '60.72', 'spread': '29.74', 'groupId': 'OG001'}, {'value': '88.53', 'spread': '100.3', 'groupId': 'OG002'}, {'value': '84.13', 'spread': '76.72', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated as:\n\nAUCinf = AUClast + Clast/λz', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'PRIMARY', 'title': 'Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition'}, {'id': 'OG001', 'title': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition'}, {'id': 'OG002', 'title': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition'}, {'id': 'OG003', 'title': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition'}], 'classes': [{'title': 'Hydrocodone', 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '2.65', 'spread': '1.78', 'groupId': 'OG002'}, {'value': '2.71', 'spread': '2.06', 'groupId': 'OG003'}]}]}, {'title': 'Promethazine (Number of Participants=19,18,20,18)', 'categories': [{'measurements': [{'value': '14.35', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '13.54', 'spread': '4.64', 'groupId': 'OG001'}, {'value': '15.15', 'spread': '7.86', 'groupId': 'OG002'}, {'value': '14.56', 'spread': '6.28', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated as:\n\nAUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf \\*100', 'unitOfMeasure': 'Percentage of AUCExtrap', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: ABDC', 'description': 'Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition\n\nTreatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition\n\nTreatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition\n\nTreatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition\n\nDosing in 4 study periods was separated by a 14-day washout period'}, {'id': 'FG001', 'title': 'Sequence 2: BCAD', 'description': 'Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition\n\nTreatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition\n\nTreatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition\n\nTreatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition\n\nDosing in 4 study periods was separated by a 14-day washout period'}, {'id': 'FG002', 'title': 'Sequence 3: CDBA', 'description': 'Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition\n\nTreatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition\n\nTreatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition\n\nTreatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition\n\nDosing in 4 study periods was separated by a 14-day washout period'}, {'id': 'FG003', 'title': 'Sequence 4: DACB', 'description': 'Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition\n\nTreatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition\n\nTreatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition\n\nTreatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition\n\nDosing in 4 study periods was separated by a 14-day washout period'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 1: Washout (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Washout (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3: Washout (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4: Washout (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Twenty healthy subjects were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Subjects'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.85', 'spread': '17.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', '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': '1', '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': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', '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': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.15', 'spread': '10.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67.83', 'spread': '10.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.43', 'spread': '2.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2015-06-04', 'resultsFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-27', 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.'}, {'measure': 'Time to Reach Maximum Concentration (Tmax)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose'}, {'measure': 'Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose'}, {'measure': 'Time of the Last Quantifiable Concentration (Tlast)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose'}, {'measure': 'Observed Elimination Rate Constant (λz)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile'}, {'measure': 'Observed Terminal Elimination Half-life (T1/2)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated as: T1/2 = ln(2)/λz'}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine', 'timeFrame': '0 (pre-dose) to 0.25 hours post-dose', 'description': 'AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'AUC0-0.50 for Hydrocodone and Promethazine', 'timeFrame': '0 (pre-dose) to 0.5 hours post-dose', 'description': 'AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'AUC0-0.75 for Hydrocodone and Promethazine', 'timeFrame': '0 (Pre-dose) to 0.75 hours post-dose', 'description': 'AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'AUC0-1.0 for Hydrocodone and Promethazine', 'timeFrame': '0 (pre-dose) to 1.0 hours post-dose', 'description': 'AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'AUC0-1.5 for Hydrocodone and Promethazine', 'timeFrame': '0 (pre-dose) to 1.5 hours post-dose', 'description': 'AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'AUC0-2.0 for Hydrocodone and Promethazine', 'timeFrame': '0 (pre-dose) to 2 hours post-dose', 'description': 'AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'AUC0-4.0 for Hydrocodone and Promethazine', 'timeFrame': '0 (pre-dose) to 4 hours post-dose', 'description': 'AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.'}, {'measure': 'Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated using the linear trapezoidal rule'}, {'measure': 'Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated as:\n\nAUCinf = AUClast + Clast/λz'}, {'measure': 'Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose', 'description': 'Calculated as:\n\nAUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf \\*100'}]}, 'conditionsModule': {'keywords': ['Plasma concentration', 'Time to plasma concentration', 'Elimination rate constant', 'Elimination half life', 'Area under the curve'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)\n* Abide by study restrictions\n* Acceptable birth control measures\n* Ability to attend all study visits\n* Vital signs as per protocol\n* Willing to consume high calorie meals within designated time frame\n\nExclusion Criteria:\n\n* Clinically significant medical history\n* Clinically significant abnormal findings\n* History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.\n* Has smoked or used tobacco products within 60 days prior to the first dose of study medication\n* Has donated blood or plasma within 30 days prior to the first dose of study medication\n* Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication."}, 'identificationModule': {'nctId': 'NCT02465866', 'briefTitle': 'A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Charleston Laboratories, Inc'}, 'officialTitle': 'A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions', 'orgStudyIdInfo': {'id': 'CLCT-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: CL-108 (Fasted)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition', 'interventionNames': ['Drug: CL-108']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: CL-108 (Fed)', 'description': 'CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition', 'interventionNames': ['Drug: CL-108']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition', 'interventionNames': ['Drug: Vicoprofen', 'Drug: Ultracet', 'Drug: Phenergan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)', 'description': 'Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition', 'interventionNames': ['Drug: Vicoprofen', 'Drug: Ultracet', 'Drug: Phenergan']}], 'interventions': [{'name': 'CL-108', 'type': 'DRUG', 'description': 'Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth', 'armGroupLabels': ['Treatment A: CL-108 (Fasted)', 'Treatment B: CL-108 (Fed)']}, {'name': 'Vicoprofen', 'type': 'DRUG', 'description': 'Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth', 'armGroupLabels': ['Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)']}, {'name': 'Ultracet', 'type': 'DRUG', 'description': 'Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth', 'armGroupLabels': ['Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)']}, {'name': 'Phenergan', 'type': 'DRUG', 'otherNames': ['Promethazine HCl'], 'description': 'Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth', 'armGroupLabels': ['Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)', 'Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charleston Laboratories, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-President, Regulatory Affairs', 'investigatorFullName': 'Joseph Hazelton', 'investigatorAffiliation': 'Charleston Laboratories, Inc'}}}}