{"protocolSection":{"identificationModule":{"nctId":"NCT01190514","orgStudyIdInfo":{"id":"B2061035"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)","officialTitle":"Phase 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions"},"statusModule":{"statusVerifiedDate":"2011-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-09"},"primaryCompletionDateStruct":{"date":"2010-11","type":"ACTUAL"},"completionDateStruct":{"date":"2010-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-08-24","studyFirstSubmitQcDate":"2010-08-26","studyFirstPostDateStruct":{"date":"2010-08-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-12-21","resultsFirstSubmitQcDate":"2011-12-21","resultsFirstPostDateStruct":{"date":"2012-01-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-12-21","lastUpdatePostDateStruct":{"date":"2012-01-27","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.\n\nTo investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS."},"conditionsModule":{"conditions":["Depression - Major Depressive Disorder"],"keywords":["DVS SR","healthy","Bioequivalence study"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":41,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bioequivalence and Food effect","type":"EXPERIMENTAL","interventionNames":["Drug: desvenlafaxine succinate sustained release"]}],"interventions":[{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Two tablets of 25 mg, single administration, under fed condition","armGroupLabels":["Bioequivalence and Food effect"],"otherNames":["DVS-233 SR, Pristiq"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"One tablet of 50 mg, single administration, under fed condition","armGroupLabels":["Bioequivalence and Food effect"],"otherNames":["DVS-233 SR, Pristiq"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"Two tablets of 25 mg, single administration, under fast condition","armGroupLabels":["Bioequivalence and Food effect"],"otherNames":["DVS-233 SR, Pristiq"]},{"type":"DRUG","name":"desvenlafaxine succinate sustained release","description":"One tablet of 50 mg, single administration, under fast condition","armGroupLabels":["Bioequivalence and Food effect"],"otherNames":["DVS-233 SR, Pristiq"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)","description":"Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng\\*hr/mL).","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose"},{"measure":"Maximum Plasma Concentration (Cmax)","description":"Cmax measured as nanograms divided by milliliters (ng/mL).","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose"}],"secondaryOutcomes":[{"measure":"Time to Reach Maximum Observed Plasma Concentration (Tmax)","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose"},{"measure":"Terminal Elimination Half-life (t 1/2)","description":"Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose"},{"measure":"Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)","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 - ∞).","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose"},{"measure":"Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy male and female subjects.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pfizer Investigational Site","city":"Brussels","zip":"B-1070","country":"Belgium","geoPoint":{"lat":50.85045,"lon":4.34878}}]},"referencesModule":{"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061035&StudyName=Phase%201%20Study%20To%20Test%20the%20Bioequivalence%20Between%20Two%2025%20mg%20Tablets%20vs.%20One%2050%20mg%20Tablet%20Under%20Fast/Fed%20Condition%20and%20Evaluate%20Food"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants randomized to an open-label treatment sequence beginning in Period 1 with 25 milligrams as 2 tablets (25 mg\\*2) in fed state=A; or a 50 mg tablet in fed state=B; or 25 mg\\*2 tablets in fasted state=C; or a 50 mg tablet in fasted state=D in a cross-over, 4-period design. Treatment groups sequenced as: ABCD, BADC, CDAB, and DCBA.","groups":[{"id":"FG000","title":"DVS SR 25 mg*2 Fed (A) First","description":"Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg\\*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing)."},{"id":"FG001","title":"DVS SR 50 mg Fed (B) First","description":"DVS SR 50 mg tablet on Day 1 of study period in fed state."},{"id":"FG002","title":"DVS SR 25 mg*2 Fasted (C) First","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing)."},{"id":"FG003","title":"DVS SR 50 mg Fasted (D) First","description":"DVS SR 50 mg tablet on Day 1 of study period in fasted state."}],"periods":[{"title":"First Intervention (Period 1)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Discontinued participant received treatment A of sequence ABCD.","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Second Intervention (Period 2)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Period 2 received treatment B","numSubjects":"10"},{"groupId":"FG001","comment":"Period 2 received treatment A","numSubjects":"10"},{"groupId":"FG002","comment":"Period 2 received treatment D","numSubjects":"10"},{"groupId":"FG003","comment":"Period 2 received treatment C","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Third Intervention (Period 3)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Period 3 received treatment C","numSubjects":"10"},{"groupId":"FG001","comment":"Period 3 received treatment D","numSubjects":"10"},{"groupId":"FG002","comment":"Period 3 received treatment A","numSubjects":"10"},{"groupId":"FG003","comment":"Period 3 received treatment B","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Discontinued participant received treatments ABC of sequence ABCD.","numSubjects":"9"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Fourth Intervention (Period 4)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Period 4 received treatment D","numSubjects":"9"},{"groupId":"FG001","comment":"Period 4 received treatment C","numSubjects":"10"},{"groupId":"FG002","comment":"Period 4 received treatment B","numSubjects":"10"},{"groupId":"FG003","comment":"Period 4 received treatment A","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Entire Study Population","description":"Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg\\*2 Fed (A); 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N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose","groups":[{"id":"OG000","title":"DVS SR 25 mg*2 Fed","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fed state."},{"id":"OG001","title":"DVS SR 50 mg Fed","description":"DVS SR 50 mg tablet on Day 1 of study period in fed state."},{"id":"OG002","title":"DVS SR 25 mg*2 Fasted","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fasted state."},{"id":"OG003","title":"DVS SR 50 mg Fasted","description":"DVS SR 50 mg tablet on Day 1 of study period in fasted state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2948","spread":"726.28"},{"groupId":"OG001","value":"2966","spread":"836.52"},{"groupId":"OG002","value":"2632","spread":"764.41"},{"groupId":"OG003","value":"2777","spread":"893.35"}]}]}],"analyses":[{"groupIds":["OG002","OG003"],"groupDescription":"DVS SR 25 mg\\*2 fasted (test); DVS SR 50 mg fasted (reference).\n\nNatural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).","statisticalMethod":"Mixed Models Analysis","paramType":"ratio (%) of adjusted geometric means","paramValue":"95.56","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"86.94","ciUpperLimit":"105.04","estimateComment":"Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference)."},{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR 25 mg\\*2 fed (test); DVS SR 50 mg fed (reference).\n\nNatural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).","statisticalMethod":"Mixed Models Analysis","paramType":"ratio (%) of adjusted geometric means","paramValue":"101.31","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"97.17","ciUpperLimit":"105.64","estimateComment":"Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference)."},{"groupIds":["OG001","OG003"],"groupDescription":"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).\n\nNatural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).","statisticalMethod":"Mixed Models Analysis","paramType":"ratio (%) of adjusted geometric means","paramValue":"108.76","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"101.10","ciUpperLimit":"117.01","estimateComment":"Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference)."}]},{"type":"SECONDARY","title":"Time to Reach Maximum Observed Plasma Concentration (Tmax)","populationDescription":"PK population; N=number of participants contributing to the median.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hours","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose","groups":[{"id":"OG000","title":"DVS SR 25 mg*2 Fed","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fed state."},{"id":"OG001","title":"DVS SR 50 mg Fed","description":"DVS SR 50 mg tablet on Day 1 of study period in fed state."},{"id":"OG002","title":"DVS SR 25 mg*2 Fasted","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fasted state."},{"id":"OG003","title":"DVS SR 50 mg Fasted","description":"DVS SR 50 mg tablet on Day 1 of study period in fasted state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.00","lowerLimit":"4.00","upperLimit":"12.0"},{"groupId":"OG001","value":"8.00","lowerLimit":"2.00","upperLimit":"12.0"},{"groupId":"OG002","value":"6.00","lowerLimit":"4.00","upperLimit":"16.0"},{"groupId":"OG003","value":"6.00","lowerLimit":"4.00","upperLimit":"24.0"}]}]}]},{"type":"PRIMARY","title":"Maximum Plasma Concentration (Cmax)","description":"Cmax measured as nanograms divided by milliliters (ng/mL).","populationDescription":"PK population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose","groups":[{"id":"OG000","title":"DVS SR 25 mg*2 Fed","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fed state."},{"id":"OG001","title":"DVS SR 50 mg Fed","description":"DVS SR 50 mg tablet on Day 1 of study period in fed state."},{"id":"OG002","title":"DVS SR 25 mg*2 Fasted","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fasted state."},{"id":"OG003","title":"DVS SR 50 mg Fasted","description":"DVS SR 50 mg tablet on Day 1 of study period in fasted state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"130.6","spread":"29.711"},{"groupId":"OG001","value":"131.0","spread":"36.308"},{"groupId":"OG002","value":"107.3","spread":"26.773"},{"groupId":"OG003","value":"112.1","spread":"28.510"}]}]}],"analyses":[{"groupIds":["OG002","OG003"],"groupDescription":"DVS SR 25 mg\\*2 fasted (test); DVS SR 50 mg fasted (reference).\n\nNatural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).","statisticalMethod":"Mixed Models Analysis","paramType":"Ratio (%) of adjusted geometric means","paramValue":"95.10","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"89.37","ciUpperLimit":"101.20","estimateComment":"Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference)."},{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR 25 mg\\*2 fed (test); DVS SR 50 mg fed (reference).\n\nNatural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).","statisticalMethod":"Mixed Models Analysis","paramType":"Ratio (%) of adjusted geometric means","paramValue":"101.30","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"94.66","ciUpperLimit":"108.40","estimateComment":"Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference)."},{"groupIds":["OG001","OG003"],"groupDescription":"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).\n\nNatural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).","statisticalMethod":"Mixed Models Analysis","paramType":"ratio (%) of adjusted geometric means","paramValue":"115.54","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"108.59","ciUpperLimit":"122.94","estimateComment":"Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference)."}]},{"type":"SECONDARY","title":"Terminal Elimination Half-life (t 1/2)","description":"Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.","populationDescription":"PK population; N=number of participants contributing to the median.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours","timeFrame":"Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose","groups":[{"id":"OG000","title":"DVS SR 25 mg*2 Fed","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fed state."},{"id":"OG001","title":"DVS SR 50 mg Fed","description":"DVS SR 50 mg tablet on Day 1 of study period in fed state."},{"id":"OG002","title":"DVS SR 25 mg*2 Fasted","description":"DVS SR 25 mg\\*2 tablets on Day 1 of study period in fasted state."},{"id":"OG003","title":"DVS SR 50 mg Fasted","description":"DVS SR 50 mg tablet on Day 1 of study period in fasted state."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.50","spread":"2.2478"},{"groupId":"OG001","value":"10.72","spread":"2.8931"},{"groupId":"OG002","value":"12.71","spread":"6.0106"},{"groupId":"OG003","value":"11.13","spread":"2.9444"}]}]}]},{"type":"SECONDARY","title":"Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)","description":"Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). 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