Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT01188668
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2010-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D000069468', 'term': 'Desvenlafaxine Succinate'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Day 27 (follow-up telephone visit)', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.', 'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.', 'otherNumAtRisk': 38, 'otherNumAffected': 14, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).', 'otherNumAtRisk': 36, 'otherNumAffected': 5, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.', 'otherNumAtRisk': 35, 'otherNumAffected': 9, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Salivary gland pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Attention deficit / hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '1494', 'spread': '699.98', 'groupId': 'OG000'}, {'value': '1604', 'spread': '561.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.97', 'ciLowerLimit': '101.39', 'ciUpperLimit': '110.76', 'estimateComment': 'Values have been back-transformed from the log scale.', 'groupDescription': 'DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng\\*hr/mL).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.66', 'spread': '7.6031', 'groupId': 'OG000'}, {'value': '24.69', 'spread': '7.4186', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.05', 'ciLowerLimit': '92.94', 'ciUpperLimit': '109.87', 'estimateComment': 'Values have been back-transformed from the log scale.', 'groupDescription': 'DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Cmax measured as nanograms per milliliters (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '8.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Time for maximum observed plasma concentration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the median.'}, {'type': 'SECONDARY', 'title': 'Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.17', 'spread': '22.191', 'groupId': 'OG000'}, {'value': '84.18', 'spread': '20.025', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Terminal half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.76', 'spread': '25.345', 'groupId': 'OG000'}, {'value': '51.92', 'spread': '19.655', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '397.3', 'spread': '129.28', 'groupId': 'OG000'}, {'value': '368.1', 'spread': '102.01', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Calculated as Dose / (AUCinf \\* kel); where kel=terminal phase rate constant.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '695.9', 'spread': '151.95', 'groupId': 'OG000'}, {'value': '685.8', 'spread': '148.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.93', 'ciLowerLimit': '94.21', 'ciUpperLimit': '112.46', 'estimateComment': 'Values have been back-transformed from the log scale.', 'groupDescription': 'DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.007', 'spread': '1.0889', 'groupId': 'OG000'}, {'value': '3.185', 'spread': '1.0127', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.27', 'ciLowerLimit': '100.97', 'ciUpperLimit': '111.85', 'estimateComment': 'Values have been back-transformed from the log scale.', 'groupDescription': 'DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '120'}, {'value': '71.9', 'groupId': 'OG001', 'lowerLimit': '23.9', 'upperLimit': '168'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Time for maximum observed plasma concentration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.78', 'spread': '16.588', 'groupId': 'OG000'}, {'value': '94.27', 'spread': '16.403', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Terminal half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. N=Number of participants contributing to the mean.'}, {'type': 'SECONDARY', 'title': 'Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. Data was insufficient for analysis; not analyzable.'}, {'type': 'SECONDARY', 'title': 'Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population. Data was insufficient for analysis; not analyzable.'}, {'type': 'SECONDARY', 'title': 'Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'title': '0 hour', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No observations above the lower limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.1290', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.813'}]}]}, {'title': '0.5 hour post dose', 'categories': [{'measurements': [{'value': '0.4800', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '6.65'}, {'value': '1.220', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '7.57'}]}]}, {'title': '1 hour post dose', 'categories': [{'measurements': [{'value': '10.69', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '26.9'}, {'value': '9.545', 'groupId': 'OG001', 'lowerLimit': '0.167', 'upperLimit': '33.1'}]}]}, {'title': '2 hours post dose', 'categories': [{'measurements': [{'value': '23.40', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '46.7'}, {'value': '21.70', 'groupId': 'OG001', 'lowerLimit': '0.824', 'upperLimit': '44.1'}]}]}, {'title': '3 hours post dose', 'categories': [{'measurements': [{'value': '21.75', 'groupId': 'OG000', 'lowerLimit': '3.01', 'upperLimit': '37.2'}, {'value': '24.40', 'groupId': 'OG001', 'lowerLimit': '8.27', 'upperLimit': '36.1'}]}]}, {'title': '4 hours post dose', 'categories': [{'measurements': [{'value': '21.35', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '35.1'}, {'value': '25.40', 'groupId': 'OG001', 'lowerLimit': '8.85', 'upperLimit': '31.9'}]}]}, {'title': '6 hours post dose', 'categories': [{'measurements': [{'value': '18.95', 'groupId': 'OG000', 'lowerLimit': '9.96', 'upperLimit': '27.9'}, {'value': '20.70', 'groupId': 'OG001', 'lowerLimit': '7.22', 'upperLimit': '25.8'}]}]}, {'title': '8 hours post dose', 'categories': [{'measurements': [{'value': '16.65', 'groupId': 'OG000', 'lowerLimit': '8.39', 'upperLimit': '23.7'}, {'value': '18.00', 'groupId': 'OG001', 'lowerLimit': '7.24', 'upperLimit': '23.8'}]}]}, {'title': '12 hours post dose', 'categories': [{'measurements': [{'value': '13.65', 'groupId': 'OG000', 'lowerLimit': '6.53', 'upperLimit': '23.7'}, {'value': '13.80', 'groupId': 'OG001', 'lowerLimit': '6.46', 'upperLimit': '19.2'}]}]}, {'title': '16 hours post dose', 'categories': [{'measurements': [{'value': '11.50', 'groupId': 'OG000', 'lowerLimit': '5.73', 'upperLimit': '18.2'}, {'value': '12.50', 'groupId': 'OG001', 'lowerLimit': '5.84', 'upperLimit': '18.7'}]}]}, {'title': '24 hours post dose', 'categories': [{'measurements': [{'value': '10.70', 'groupId': 'OG000', 'lowerLimit': '5.35', 'upperLimit': '18.1'}, {'value': '12.20', 'groupId': 'OG001', 'lowerLimit': '5.47', 'upperLimit': '18.6'}]}]}, {'title': '48 hours post dose', 'categories': [{'measurements': [{'value': '8.310', 'groupId': 'OG000', 'lowerLimit': '3.88', 'upperLimit': '14.2'}, {'value': '8.940', 'groupId': 'OG001', 'lowerLimit': '4.64', 'upperLimit': '13.5'}]}]}, {'title': '72 hours post dose', 'categories': [{'measurements': [{'value': '6.255', 'groupId': 'OG000', 'lowerLimit': '2.46', 'upperLimit': '11.6'}, {'value': '6.870', 'groupId': 'OG001', 'lowerLimit': '3.36', 'upperLimit': '11.1'}]}]}, {'title': '120 hours post dose', 'categories': [{'measurements': [{'value': '3.680', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '10.1'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '1.88', 'upperLimit': '7.82'}]}]}, {'title': '168 hours post dose', 'categories': [{'measurements': [{'value': '2.390', 'groupId': 'OG000', 'lowerLimit': '0.926', 'upperLimit': '16.3'}, {'value': '2.720', 'groupId': 'OG001', 'lowerLimit': '0.872', 'upperLimit': '5.53'}]}]}, {'title': '216 hours post dose', 'categories': [{'measurements': [{'value': '1.730', 'groupId': 'OG000', 'lowerLimit': '0.491', 'upperLimit': '13.4'}, {'value': '1.960', 'groupId': 'OG001', 'lowerLimit': '0.457', 'upperLimit': '4.30'}]}]}, {'title': '264 hours post dose', 'categories': [{'measurements': [{'value': '1.080', 'groupId': 'OG000', 'lowerLimit': '0.337', 'upperLimit': '4.41'}, {'value': '1.340', 'groupId': 'OG001', 'lowerLimit': '0.237', 'upperLimit': '3.20'}]}]}, {'title': '312 hours post dose', 'categories': [{'measurements': [{'value': '0.8040', 'groupId': 'OG000', 'lowerLimit': '0.202', 'upperLimit': '3.99'}, {'value': '1.010', 'groupId': 'OG001', 'lowerLimit': '0.128', 'upperLimit': '2.58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing', 'description': 'Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.'}, {'type': 'SECONDARY', 'title': 'Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 5 mg (Period 1)', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.'}, {'id': 'OG001', 'title': 'Aripiprazole 5 mg + DVS SR 100 mg (Period 2)', 'description': 'DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'classes': [{'title': '0 hour', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No observations above the lower limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.1640', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.871'}]}]}, {'title': '0.5 hour post dose', 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.138'}, {'value': '0.2120', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.950'}]}]}, {'title': '1 hour post dose', 'categories': [{'measurements': [{'value': '0.2740', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '1.38'}, {'value': '0.5965', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '1.64'}]}]}, {'title': '2 hours post dose', 'categories': [{'measurements': [{'value': '0.9470', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '4.29'}, {'value': '1.240', 'groupId': 'OG001', 'lowerLimit': '0.132', 'upperLimit': '2.64'}]}]}, {'title': '3 hours post dose', 'categories': [{'measurements': [{'value': '1.260', 'groupId': 'OG000', 'lowerLimit': '0.115', 'upperLimit': '5.55'}, {'value': '1.660', 'groupId': 'OG001', 'lowerLimit': '0.473', 'upperLimit': '3.33'}]}]}, {'title': '4 hours post dose', 'categories': [{'measurements': [{'value': '1.495', 'groupId': 'OG000', 'lowerLimit': '0.277', 'upperLimit': '5.38'}, {'value': '1.880', 'groupId': 'OG001', 'lowerLimit': '0.791', 'upperLimit': '4.13'}]}]}, {'title': '6 hours post dose', 'categories': [{'measurements': [{'value': '1.650', 'groupId': 'OG000', 'lowerLimit': '0.453', 'upperLimit': '5.57'}, {'value': '1.910', 'groupId': 'OG001', 'lowerLimit': '0.686', 'upperLimit': '4.72'}]}]}, {'title': '8 hours post dose', 'categories': [{'measurements': [{'value': '1.780', 'groupId': 'OG000', 'lowerLimit': '0.689', 'upperLimit': '5.80'}, {'value': '1.910', 'groupId': 'OG001', 'lowerLimit': '0.686', 'upperLimit': '5.29'}]}]}, {'title': '12 hours post dose', 'categories': [{'measurements': [{'value': '1.845', 'groupId': 'OG000', 'lowerLimit': '0.748', 'upperLimit': '5.35'}, {'value': '1.950', 'groupId': 'OG001', 'lowerLimit': '0.654', 'upperLimit': '5.15'}]}]}, {'title': '16 hours post dose', 'categories': [{'measurements': [{'value': '2.010', 'groupId': 'OG000', 'lowerLimit': '0.819', 'upperLimit': '5.16'}, {'value': '1.970', 'groupId': 'OG001', 'lowerLimit': '0.695', 'upperLimit': '4.77'}]}]}, {'title': '24 hours post dose', 'categories': [{'measurements': [{'value': '2.520', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '6.29'}, {'value': '2.550', 'groupId': 'OG001', 'lowerLimit': '0.952', 'upperLimit': '5.68'}]}]}, {'title': '48 hours post dose', 'categories': [{'measurements': [{'value': '3.135', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '5.79'}, {'value': '3.160', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '5.43'}]}]}, {'title': '72 hours post dose', 'categories': [{'measurements': [{'value': '2.935', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '4.61'}, {'value': '3.020', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '6.08'}]}]}, {'title': '120 hours post dose', 'categories': [{'measurements': [{'value': '2.440', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '4.16'}, {'value': '2.360', 'groupId': 'OG001', 'lowerLimit': '1.14', 'upperLimit': '4.16'}]}]}, {'title': '168 hours post dose', 'categories': [{'measurements': [{'value': '1.920', 'groupId': 'OG000', 'lowerLimit': '0.996', 'upperLimit': '3.76'}, {'value': '1.980', 'groupId': 'OG001', 'lowerLimit': '1.09', 'upperLimit': '3.43'}]}]}, {'title': '216 hours post dose', 'categories': [{'measurements': [{'value': '1.570', 'groupId': 'OG000', 'lowerLimit': '0.650', 'upperLimit': '3.17'}, {'value': '1.460', 'groupId': 'OG001', 'lowerLimit': '0.744', 'upperLimit': '2.96'}]}]}, {'title': '264 hours post dose', 'categories': [{'measurements': [{'value': '1.080', 'groupId': 'OG000', 'lowerLimit': '0.429', 'upperLimit': '3.13'}, {'value': '1.130', 'groupId': 'OG001', 'lowerLimit': '0.454', 'upperLimit': '2.57'}]}]}, {'title': '312 hours post dose', 'categories': [{'measurements': [{'value': '0.8660', 'groupId': 'OG000', 'lowerLimit': '0.248', 'upperLimit': '2.85'}, {'value': '0.9680', 'groupId': 'OG001', 'lowerLimit': '0.252', 'upperLimit': '2.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing', 'description': 'Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg', 'description': 'Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'periods': [{'title': 'Period 1: ARIP Alone', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Period 2: Coadministration ARIP + DVS SR', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg', 'description': 'Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2010-08-24', 'resultsFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-09', 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng\\*hr/mL).'}], 'secondaryOutcomes': [{'measure': 'Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Cmax measured as nanograms per milliliters (ng/mL).'}, {'measure': 'Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Time for maximum observed plasma concentration.'}, {'measure': 'Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Terminal half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).'}, {'measure': 'Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Calculated as Dose / (AUCinf \\* kel); where kel=terminal phase rate constant.'}, {'measure': 'Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': 'Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing'}, {'measure': 'Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Time for maximum observed plasma concentration.'}, {'measure': 'Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Terminal half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).'}, {'measure': 'Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR', 'timeFrame': 'Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20'}, {'measure': 'Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg', 'timeFrame': 'Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing', 'description': 'Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.'}, {'measure': 'Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg', 'timeFrame': 'Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing', 'description': 'Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetic', 'safety and tolerability', 'genetic testing', 'CYP 2D6 and CYP 3A4'], 'conditions': ['Pharmacokinetics', 'Cytochrome P-450 CYP2D6', 'CYP3A4 Protein, Human']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coadministered to healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 55 years\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \\>50 kg (110 lbs)\n* Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history\n* An informed consent document signed and dated by the subject\n\nExclusion Criteria:\n\n* History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic disease\n* History of seizure disorder\n* Presence or history of glaucoma or increased intraocular pressure\n* Allergy to or unable to tolerate aripiprazole, desvenlafaxine, or venlafaxine\n* History of substance abuse within 1 year of study\n* A positive urine drug screen\n* Treatment with an investigational drug within 30 days\n* Consumption of grapefruit or grapefruit related citrus fruits\n* 12 lead ECG demonstrating QTc \\>450 msec at screening\n* Pregnant or nursing females\n* Use of prescription or nonprescription drugs and dietary supplements\n* History of sensitivity to heparin or heparin induced thrombocytopenia\n* Severe acute or chronic medical or psychiatric condition or laboratory abnormality'}, 'identificationModule': {'nctId': 'NCT01188668', 'briefTitle': 'Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label, 2-Period Sequential Drug Interaction Study To Evaluate The Effect Of A 100 Mg Dose Of Desvenlafaxine SR On The Pharmacokinetics Of Aripiprazole When Coadministered In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B2061026'}, 'secondaryIdInfos': [{'id': '3151A1-1207'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aripiprazole + Desvenlafaxine SR', 'interventionNames': ['Drug: Aripiprazole', 'Drug: Aripiprazole + desvenlafaxine succinate sustained release']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['DVS-233; Pristiq'], 'description': 'Period 1-Aripiprazole 5mg on study day 1.', 'armGroupLabels': ['Aripiprazole + Desvenlafaxine SR']}, {'name': 'Aripiprazole + desvenlafaxine succinate sustained release', 'type': 'DRUG', 'description': 'Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.', 'armGroupLabels': ['Aripiprazole + Desvenlafaxine SR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33134', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}