{"protocolSection":{"identificationModule":{"nctId":"NCT00952653","orgStudyIdInfo":{"id":"3151A1-1205"},"secondaryIdInfos":[{"id":"B2061001"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam","officialTitle":"An Open-Label, Two-Period, Sequential Drug Interaction Study to Evaluate the Effect of Multiple Doses of Desvenlafaxine Succinate Sustained Release (DVS SR) on the Pharmacokinetics of Midazolam When Coadministered in Healthy Subjects"},"statusModule":{"statusVerifiedDate":"2011-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-06"},"primaryCompletionDateStruct":{"date":"2010-08","type":"ACTUAL"},"completionDateStruct":{"date":"2010-08","type":"ACTUAL"},"studyFirstSubmitDate":"2009-08-03","studyFirstSubmitQcDate":"2009-08-04","studyFirstPostDateStruct":{"date":"2009-08-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-07-06","resultsFirstSubmitQcDate":"2011-07-06","resultsFirstPostDateStruct":{"date":"2011-08-02","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-08-09","lastUpdatePostDateStruct":{"date":"2011-08-15","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Director, Clinical Trial Disclosure Group","oldOrganization":"Pfizer, Inc"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":28,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"DVS SR","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine Succinate Sustained Release","Drug: Midazolam"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained Release","description":"50 mg DVS SR tablet days 1-6, period 2 only.","armGroupLabels":["DVS SR"]},{"type":"DRUG","name":"Midazolam","description":"4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.","armGroupLabels":["DVS SR"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR","description":"AUCinf measured as nanograms multiplied by hours divided by milliliters (ng\\*hr/mL).","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR","description":"Cmax measured as nanograms per milliliters (ng/mL).","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR","description":"1-Hydroxy-Midazolam is an analyte of Midazolam.","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"}],"secondaryOutcomes":[{"measure":"Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"},{"measure":"1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at screening.\n* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).\n* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 Ilbs).\n\nExclusion Criteria:\n\n* Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.\n* Presence or history of glaucoma or intraocular pressure.\n* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.\n* Allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine.\n* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before study day 1.\n* Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. History of drug abuse within 1 year before study day 1.","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":"New Haven","state":"Connecticut","zip":"06511","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]},"referencesModule":{"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-1205&StudyName=Study%20Evaluating%20the%20Effect%20of%20Desvenlafaxine%20on%20the%20Pharmacokinetics%20of%20Midazolam"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"DVS SR 50 mg, Midazolam 4 mg","description":"Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter \\[mg/mL\\]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"periods":[{"title":"Period 1: MDZ Alone","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]},{"title":"Period 2: Coadministration DVS SR, MDZ","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"DVS SR 50 mg, Midazolam 4 mg","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"28"}]}],"measures":[{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"18 to 25 years","categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}]},{"title":"26 to 35 years","categories":[{"measurements":[{"groupId":"BG000","value":"9"}]}]},{"title":"36 to 45 years","categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}]},{"title":"> 45 years","categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"12"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"16"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR","description":"AUCinf measured as nanograms multiplied by hours divided by milliliters (ng\\*hr/mL).","populationDescription":"PK parameter analysis population: all enrolled 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.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54.69","spread":"26.670"},{"groupId":"OG001","value":"39.45","spread":"13.301"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \\[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\\], where overall study power is to be based on the product of the individual powers of the parameters of interest.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted geometric means","paramValue":"71.40","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"65.08","ciUpperLimit":"78.33","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"PRIMARY","title":"Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR","description":"Cmax measured as nanograms per milliliters (ng/mL).","populationDescription":"PK parameter analysis population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.20","spread":"7.1216"},{"groupId":"OG001","value":"18.24","spread":"5.1116"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \\[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\\], where overall study power is to be based on the product of the individual powers of the parameters of interest.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted geometric means","paramValue":"86.08","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"79.04","ciUpperLimit":"93.74","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"PRIMARY","title":"1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR","description":"1-Hydroxy-Midazolam is an analyte of Midazolam.","populationDescription":"PK parameter analysis population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36.87","spread":"28.230"},{"groupId":"OG001","value":"30.74","spread":"14.649"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \\[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\\], where overall study power is to be based on the product of the individual powers of the parameters of interest.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted geometric means","paramValue":"92.55","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"87.43","ciUpperLimit":"97.97","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"PRIMARY","title":"1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.93","spread":"6.5282"},{"groupId":"OG001","value":"15.10","spread":"6.2472"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \\[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\\], where overall study power is to be based on the product of the individual powers of the parameters of interest.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted geometric means","paramValue":"101.17","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"92.96","ciUpperLimit":"110.11","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"SECONDARY","title":"Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.85","spread":"23.980"},{"groupId":"OG001","value":"38.11","spread":"12.522"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR + Midazolam (test) versus Midazolam (reference)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted geometric means","paramValue":"72.10","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"66.04","ciUpperLimit":"78.72","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"SECONDARY","title":"Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; N=number of participants contributing to the median.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hr","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.517","lowerLimit":"0.250","upperLimit":"1.50"},{"groupId":"OG001","value":"0.500","lowerLimit":"0.250","upperLimit":"1.02"}]}]}]},{"type":"SECONDARY","title":"Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hr","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"25"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.320","spread":"1.5948"},{"groupId":"OG001","value":"4.648","spread":"1.7436"}]}]}]},{"type":"SECONDARY","title":"1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; N=number of participants contributing to the mean.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*hr/mL","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.09","spread":"25.371"},{"groupId":"OG001","value":"32.42","spread":"14.881"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR + Midazolam (test) versus Midazolam (reference)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted geometric means","paramValue":"87.39","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"80.42","ciUpperLimit":"94.96","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"SECONDARY","title":"1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; N=number of participants contributing to the median.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hr","timeFrame":"Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing","groups":[{"id":"OG000","title":"Midazolam 4 mg (Period 1)","description":"Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"DVS SR 50 mg, Midazolam 4 mg (Period 2)","description":"DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","lowerLimit":"0.250","upperLimit":"1.50"},{"groupId":"OG001","value":"0.500","lowerLimit":"0.250","upperLimit":"1.02"}]}]}]},{"type":"SECONDARY","title":"1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population; 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