{"protocolSection":{"identificationModule":{"nctId":"NCT01189500","orgStudyIdInfo":{"id":"B2061027"},"secondaryIdInfos":[{"id":"3151A1-1206"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects","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 Tamoxifen When Co-Administered In Healthy Post-Menopausal Female Subjects"},"statusModule":{"statusVerifiedDate":"2011-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-08"},"primaryCompletionDateStruct":{"date":"2010-10","type":"ACTUAL"},"completionDateStruct":{"date":"2010-10","type":"ACTUAL"},"studyFirstSubmitDate":"2010-08-25","studyFirstSubmitQcDate":"2010-08-25","studyFirstPostDateStruct":{"date":"2010-08-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-09-09","resultsFirstSubmitQcDate":"2011-09-09","resultsFirstPostDateStruct":{"date":"2011-10-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-11-01","lastUpdatePostDateStruct":{"date":"2011-11-07","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects."},"conditionsModule":{"conditions":["Pharmacokinetics"],"keywords":["Pharmacokinetic","safety and tolerability","genetic testing","CYP 2D6"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Tamoxifen and Desvenlafaxine SR","type":"EXPERIMENTAL","interventionNames":["Drug: Tamoxifen","Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release"]}],"interventions":[{"type":"DRUG","name":"Tamoxifen","description":"Period 1-Tamoxifen 40mg on study day 1.","armGroupLabels":["Tamoxifen and Desvenlafaxine SR"]},{"type":"DRUG","name":"Tamoxifen and Desvenlafaxine Succinate Sustained Release","description":"Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.","armGroupLabels":["Tamoxifen and Desvenlafaxine SR"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","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).","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR","description":"Endoxifen is a metabolite of Tamoxifen. 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":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."}],"secondaryOutcomes":[{"measure":"Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Cmax measured as nanograms per milliliters (ng/mL).","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Time for maximum observed plasma concentration.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","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).","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Calculated as Dose / (AUCinf \\* kel); where kel=terminal phase rate constant.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen 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, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Time for maximum observed plasma concentration.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","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).","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen 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, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"N-desmethyl-tamoxifen is a metabolite of Tamoxifen. 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":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen 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, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Time for maximum observed plasma concentration.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","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).","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen 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, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"4-hydroxy-tamoxifen is a metabolite of Tamoxifen. 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":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen 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, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Time for maximum observed plasma concentration.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half.","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","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).","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen 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, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"measure":"Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","description":"Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.","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, 312, 384, 456, and 528 hours after dosing"},{"measure":"Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","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.","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, 312, 384, 456, and 528 hours after dosing"},{"measure":"Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","description":"Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.","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, 312, 384, 456, and 528 hours after dosing"},{"measure":"Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","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.","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, 312, 384, 456, and 528 hours after dosing"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy post-menopausal female subjects, at least 45 years of age, with confirmed post-menopausal status\n* Hysterectomized subjects\n* Body Mass Index (BMI) less than or equal to 34.0 kg/m2\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* Presence or history of deep vein thrombosis or transient ischemic attack\n* History of seizure disorder\n* Presence or history of glaucoma or increased intraocular pressure\n* Allergy to or unable to tolerate tamoxifen, 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\n* Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"45 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Pfizer Investigational Site","city":"Miami","state":"Florida","zip":"33126","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Pfizer Investigational Site","city":"Miami","state":"Florida","zip":"33134","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}}]},"referencesModule":{"references":[{"pmid":"25138680","type":"DERIVED","citation":"Nichols AI, Lubaczewski S, Liang Y, Matschke K, Braley G, Ramey T. Open-label, 2-period sequential drug interaction study to evaluate the effect of a 100-mg dose of desvenlafaxine on the pharmacokinetics of tamoxifen when coadministered in healthy postmenopausal female subjects. Int J Clin Pharmacol Ther. 2014 Oct;52(10):830-41. doi: 10.5414/CP201958."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg","description":"Tamoxifen (TAMOX) 40 milligrams (mg) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7."}],"periods":[{"title":"Period 1: TAMOX Alone","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]},{"title":"Period 2: Coadministration TAMOX+DVS SR","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"29"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg","description":"Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. DVS SR 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"}]}],"measures":[{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"45 to 64 years","categories":[{"measurements":[{"groupId":"BG000","value":"27"}]}]},{"title":"≥65 years","categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]}]},{"title":"Sex/Gender, Customized","description":"Female","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","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).","populationDescription":"Pharmacokinetic (PK) parameter analysis population: all participants randomized and treated 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: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","groups":[{"id":"OG000","title":"Tamoxifen 40 mg (Period 1)","description":"Tamoxifen 40 mg as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"Tamoxifen 40 mg + DVS SR 100 mg (Period 2)","description":"DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5751","spread":"1540.1"},{"groupId":"OG001","value":"5888","spread":"1905.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted means","paramValue":"100.69","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"96.70","ciUpperLimit":"104.85","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"PRIMARY","title":"Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR","description":"Endoxifen is a metabolite of Tamoxifen. 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 - ∞).","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: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","groups":[{"id":"OG000","title":"Tamoxifen 40 mg (Period 1)","description":"Tamoxifen 40 mg as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"Tamoxifen 40 mg + DVS SR 100 mg (Period 2)","description":"DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. 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A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"26"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"117.5","spread":"55.433"},{"groupId":"OG001","value":"133.9","spread":"62.784"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"ratio of adjusted means","paramValue":"105.60","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"99.74","ciUpperLimit":"111.81","estimateComment":"Values have been back-transformed from the log scale."}]},{"type":"SECONDARY","title":"4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR","populationDescription":"PK parameter analysis population. 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Data was insufficient for analysis; not analyzable.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"liters","timeFrame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","groups":[{"id":"OG000","title":"Tamoxifen 40 mg (Period 1)","description":"Tamoxifen 40 mg as a single oral dose Period 1 / Day 1."},{"id":"OG001","title":"Tamoxifen 40 mg + DVS SR 100 mg (Period 2)","description":"DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. 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quantification."},{"groupId":"OG001","value":"0.3430","lowerLimit":"0.000","upperLimit":"1.03"}]}]},{"title":"2 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"0.0000","lowerLimit":"0.000","upperLimit":"0.126"},{"groupId":"OG001","value":"0.4100","lowerLimit":"0.102","upperLimit":"1.15"}]}]},{"title":"3 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"0.0000","lowerLimit":"0.000","upperLimit":"0.275"},{"groupId":"OG001","value":"0.5020","lowerLimit":"0.000","upperLimit":"1.14"}]}]},{"title":"4 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"0.1760","lowerLimit":"0.000","upperLimit":"0.590"},{"groupId":"OG001","value":"0.6350","lowerLimit":"0.119","upperLimit":"1.26"}]}]},{"title":"6 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"0.2485","lowerLimit":"0.000","upperLimit":"0.516"},{"groupId":"OG001","value":"0.5870","lowerLimit":"0.000","upperLimit":"1.00"}]}]},{"title":"8 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dose","categories":[{"measurements":[{"groupId":"OG000","value":"4.210","lowerLimit":"0.310","upperLimit":"9.46"},{"groupId":"OG001","value":"9.770","lowerLimit":"4.51","upperLimit":"16.7"}]}]},{"title":"3 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"9.440","lowerLimit":"1.03","upperLimit":"20.2"},{"groupId":"OG001","value":"14.80","lowerLimit":"6.30","upperLimit":"26.4"}]}]},{"title":"4 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"12.55","lowerLimit":"2.67","upperLimit":"20.7"},{"groupId":"OG001","value":"18.70","lowerLimit":"9.09","upperLimit":"29.9"}]}]},{"title":"6 hours post dose","categories":[{"measurements":[{"groupId":"OG000","value":"14.10","lowerLimit":"7.61","upperLimit":"23.3"},{"groupId":"OG001","value":"19.30","lowerLimit":"11.8","upperLimit":"26.1"}]}]},{"title":"8 hours post 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