Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03649750
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2018-08-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D006140', 'term': 'Guaifenesin'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006139', 'term': 'Guaiacol'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalrequests@rb.com', 'title': 'Clinical Research Director, Clinical Research', 'organization': 'Reckitt Benckiser Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 8.3 days/ (200 hours)', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 8, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 10, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vessel puncture site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1066.11', 'spread': '429.91', 'groupId': 'OG000'}, {'value': '1117.31', 'spread': '424.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Maximum measured analyte concentration over the sampling period.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Dataset are the Subjects from whom the observation/estimation of Cmax and AUC measures/parameters will be possible for two periods will be included in the PK dataset.\n\nThe PK dataset will be defined prior to the assay of samples.'}, {'type': 'PRIMARY', 'title': 'Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '4052.10', 'spread': '1495.48', 'groupId': 'OG000'}, {'value': '4084.90', 'spread': '1380.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.', 'unitOfMeasure': 'ng·h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Dataset'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Time of the maximum measured analyte concentration over the sampling period.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Dataset'}, {'type': 'SECONDARY', 'title': 'Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '4104.47', 'spread': '1555.87', 'groupId': 'OG000'}, {'value': '4092.53', 'spread': '1382.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'The area under the analyte concentration versus time curve from time zero to infinity.\n\nAUCinf = AUCt + Cp/Kel,\n\nwhere Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.', 'unitOfMeasure': 'ng·h/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Dataset'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Rate Constant (Kel) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3862', 'spread': '0.1717', 'groupId': 'OG000'}, {'value': '0.6788', 'spread': '0.1343', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Elimination rate constant calculated from the slope of the terminal portion of the plasma profile calculated by least-squares regression of log (concentration) versus time.', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Dataset'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (T½) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.46', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Terminal elimination half-life, calculated from the equation: thalf = In(2)/Kel.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Dataset'}, {'type': 'SECONDARY', 'title': 'Relative Bioavailability (RF) of Guaifenesin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting and fed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0081', 'spread': '0.1655', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Relative bioavailability for each formulation will be defined as:\n\n(AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose)', 'unitOfMeasure': 'Percent bioavailability', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome involved analyzing data from both intervention groups (Fed and Fasting) in combination as per the provided formula, therefore, separate analysis for each intervention cannot be reported'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events(AEs) Experienced by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: Mucinex® 600 mg (Fast)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.'}, {'id': 'OG001', 'title': 'Treatment B: Mucinex® 600 mg (Fed)', 'description': 'Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.'}], 'classes': [{'title': 'TEAE by severity: Mild', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'TEAE by severity: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE by severity: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Unassessable/Unclassifiable', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Conditional /Unclassified', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Unrelated', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Unlikely', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Possible', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Probable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Relationship to IMP: Certain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to period 2 (8.3 days/200 hours)', 'description': 'Intensity determination Mild=AE does not limit usual activities;subject may experience slight discomfort Moderate=AE results in some limitation of usual activities;subject may experience significant discomfort Severe=AE results in an inability to carry out usual activities;subject may experience intolerable discomfort or pain Unassessable/Unclassifiable=Insufficient information to be able to make an assessment Conditional/Unclassified=Insufficient information to make an assessment at present(causality is conditional on additional information) Unrelated=No possibility that the AE was caused by study drug Unlikely=Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug Probable=Most likely that the AE was caused by study drug Certain=The AE was definitely caused by study drug', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Dataset\n\nInvestigational Medicinal Product(IMP)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1(Mucinex Fed or Mucinex Fast in Period 1 and Period 2)', 'description': 'Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.\n\nTreatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.\n\nCohort 1\n\nPeriod 1 - Treatment A or Treatment B at Sequence AB.\n\nPeriod 2 - Treatment B or Treatment A at Sequence BA.\n\nScheduled Washout of 7 days between drug doses.'}, {'id': 'FG001', 'title': 'Cohort 2(Mucinex Fast or Mucinex Fed in Period 1 and Period 2)', 'description': 'Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.\n\nTreatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.\n\nCohort 2\n\nPeriod 1 - Treatment A or Treatment B at Sequence AB.\n\nPeriod 2 - Treatment B or Treatment A at Sequence BA.\n\nScheduled Washout of 7 days between drug doses.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout: 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a single-centre study.', 'preAssignmentDetails': 'Total Thirty-six (36) subjects were enrolled in the study among them 36 subjects completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pharmacokinetic (PK) Dataset', 'description': 'Treatment A (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under overnight fasting.\n\nTreatment B (Test): Single dose Mucinex® 600 mg Extended Release bi-layer tablet by mouth under high calorie breakfast fed.\n\nCohort 1\n\nPeriod 1 - Treatment A or Treatment B at Sequence AB.\n\nPeriod 2 - Treatment B or Treatment A at Sequence BA.\n\nScheduled Washout of 7 days between drug doses.\n\nCohort 2\n\nPeriod 1 - Treatment A or Treatment B at Sequence AB.\n\nPeriod 2 - Treatment B or Treatment A at Sequence BA.\n\nScheduled Washout of 7 days between drug doses.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.8', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age', 'classes': [{'title': '18 - 40 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': '41 - 64 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Pharmacokinetic (PK) Dataset Subjects from whom the observation/estimation of Cmax and AUC measures/parameters were possible for two periods were included in the PK dataset.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2018-08-20', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-08', 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Maximum measured analyte concentration over the sampling period.'}, {'measure': 'Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.'}], 'secondaryOutcomes': [{'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Time of the maximum measured analyte concentration over the sampling period.'}, {'measure': 'Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'The area under the analyte concentration versus time curve from time zero to infinity.\n\nAUCinf = AUCt + Cp/Kel,\n\nwhere Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.'}, {'measure': 'Terminal Elimination Rate Constant (Kel) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Elimination rate constant calculated from the slope of the terminal portion of the plasma profile calculated by least-squares regression of log (concentration) versus time.'}, {'measure': 'Terminal Elimination Half-life (T½) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Terminal elimination half-life, calculated from the equation: thalf = In(2)/Kel.'}, {'measure': 'Relative Bioavailability (RF) of Guaifenesin', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)', 'description': 'Relative bioavailability for each formulation will be defined as:\n\n(AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose)'}, {'measure': 'Number of Adverse Events(AEs) Experienced by Participants', 'timeFrame': 'Up to period 2 (8.3 days/200 hours)', 'description': 'Intensity determination Mild=AE does not limit usual activities;subject may experience slight discomfort Moderate=AE results in some limitation of usual activities;subject may experience significant discomfort Severe=AE results in an inability to carry out usual activities;subject may experience intolerable discomfort or pain Unassessable/Unclassifiable=Insufficient information to be able to make an assessment Conditional/Unclassified=Insufficient information to make an assessment at present(causality is conditional on additional information) Unrelated=No possibility that the AE was caused by study drug Unlikely=Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug Probable=Most likely that the AE was caused by study drug Certain=The AE was definitely caused by study drug'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent was obtained (i.e. be informed of the nature of the study and given written consent prior to any study procedure). Able to read, understand, and sign the informed consent, after the nature of the study had been explained.\n2. Age: 18 to 55 years of age, inclusive.\n3. Sex: male or female.\n4. Status: Healthy subjects.\n5. BMI: ≥18.0 and ≤28.0 kg/m2.\n6. No clinically significant findings in vital signs measurements at screening.\n7. No clinically significant abnormal laboratory values at screening.\n8. No clinically significant findings from a 12-lead electrocardiogram (ECG) at screening.\n9. Had no significant diseases or clinically relevant medical condition in the opinion of the Investigator\n10. Males who participated in this study were willing to:\n\n * remain abstinent \\[not engage in sexual intercourse\\] from the start of drug administration until 90 days after the end of the study or\n * used (or their partner used, as applicable) two effective methods of birth control \\[condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, vasectomy, or hormonal contraceptives\\] from the start of drug administration until 90 days after the end of the study.\n\n Females who participated in this study were:\n * unable to have children (e.g., post-menopausal, hysterectomy);\n * willing to remain abstinent \\[not engage in sexual intercourse\\] from 21 days prior to drug administration until 30 days after the end of the study; or\n * willing to use two effective methods of birth control \\[condom, diaphragm, cervical cap, vaginal sponge, spermicide, non-hormonal Intrauterine Device (IUD) (in place for 3 months), tubal ligation, partner has vasectomy, hormonal contraceptives for 3 months prior to drug administration\\] from 30 days prior to drug administration until 30 days after the end of the study.\n11. Had no clinically significant findings from a physical examination.\n\nExclusion Criteria:\n\n1. Employee of Pharma Medica Research Inc. (PMRI) or Reckitt Benckiser.\n2. Partner or first-degree relative of any Investigator at PMRI.\n3. Known history or presence of any clinically significant medical condition.\n4. Known or suspected carcinoma.\n5. Presence of hepatic or renal dysfunction.\n6. Presence of clinically significant gastrointestinal disease or history of malabsorption within the year preceding the study.\n7. Known history or presence of galactose or fructose intolerance, sucrase-isomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.\n8. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.\n9. History of drug or alcohol or medicinal product addiction requiring treatment within the two years preceding the study or excessive alcohol consumption (more than 10 units per week)\n\n Note: one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits.\n10. Positive test result for serum Human Chorionic Gonadotropin (hCG) consistent with pregnancy (females only), HIV, Hepatitis B surface antigen or Hepatitis C antibody.\n11. Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone and benzodiazepines) or urine cotinine.\n12. Difficulty fasting or consuming standard meals.\n13. Females who were lactating.\n14. Did not tolerate venipuncture.\n15. Use of tobacco or nicotine-containing products within 12 months prior to drug administration.\n16. On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).\n17. Donation or loss of whole blood (including clinical trials):\n\n * ≥50 ml and ≤499 ml within 30 days prior to drug administration\n * ≥500 ml within 56 days prior to drug administration\n18. Females who had started taking hormonal contraceptives or had changed their method or brand of hormonal birth control within 3 months prior to drug administration.\n19. Had a tattoo or body piercing within 30 days prior to drug administration.\n20. Use of drugs of the monoamine oxidase inhibitor (MAOI) class within 30 days prior to drug administration.\n21. Known history or presence of hypersensitivity, intolerance or idiosyncratic reaction to guaifenesin or any other drug substances with similar activity.\n22. Previously enrolled in this study.\n23. Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.\n24. Unable in the opinion of the Investigator to comply fully with the study requirements.'}, 'identificationModule': {'nctId': 'NCT03649750', 'briefTitle': 'Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reckitt Benckiser LLC'}, 'officialTitle': 'A Phase I, Open-label, Single-dose, Randomized, 2-way Cross-over Study Designed to Examine the Relative Bioavailability of Guaifenesin When a Mucinex Extended Release 600 mg Bi-layer Tablet is Taken Under Fasted Compared to Fed Conditions in Normal Healthy Volunteers', 'orgStudyIdInfo': {'id': '2013-MUC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: Mucinex® 600 mg (fast)', 'description': 'Mucinex® 600 mg ER bi-layer tablet by mouth after 10 hours fasting and subject will fast at least 4 hours post-dose', 'interventionNames': ['Drug: Mucinex®']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Mucinex® 600 mg (fed)', 'description': 'Mucinex® 600 mg ER bi-layer tablet by mouth in fed condition. After an overnight fast of at least 10 hours, subjects will consume a high fat, high calorie breakfast starting 30 minutes prior to drug administration', 'interventionNames': ['Drug: Mucinex®']}], 'interventions': [{'name': 'Mucinex®', 'type': 'DRUG', 'otherNames': ['guaifenesin'], 'description': 'Mucinex® 600 mg ER bi-layer tablets', 'armGroupLabels': ['Treatment A: Mucinex® 600 mg (fast)', 'Treatment B: Mucinex® 600 mg (fed)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reckitt Benckiser LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}