Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 89 for:    DESVENLAFAXINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189500
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : October 17, 2011
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Pharmacokinetics
Interventions Drug: Tamoxifen
Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg
Hide Arm/Group 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.
Period Title: Period 1: TAMOX Alone
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Adverse Event             1
Period Title: Period 2: Coadministration TAMOX+DVS SR
Started 29
Completed 28
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg
Hide Arm/Group 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.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
45 to 64 years 27
≥65 years 3
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
30
[1]
Measure Description: Female
1.Primary Outcome
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
Hide 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
5751  (1540.1) 5888  (1905.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen 40 mg (Period 1), Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 100.69
Confidence Interval (2-Sided) 90%
96.70 to 104.85
Estimation Comments Values have been back-transformed from the log scale.
2.Primary Outcome
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
Hide 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 - ∞).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 4 4
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
677.7  (200.42) 505.6  (220.87)
3.Secondary Outcome
Title Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Cmax measured as nanograms per milliliters (ng/mL).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
70.58  (16.310) 70.33  (14.484)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen 40 mg (Period 1), Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 99.44
Confidence Interval (2-Sided) 90%
94.02 to 105.17
Estimation Comments Values have been back-transformed from the log scale.
4.Secondary Outcome
Title Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Time for maximum observed plasma concentration.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the median.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: hours
4.00
(3.00 to 8.00)
4.00
(3.00 to 8.00)
5.Secondary Outcome
Title Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: hours
250.5  (44.410) 242.3  (51.851)
6.Secondary Outcome
Title Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: mL/min
115.9  (34.544) 113.2  (44.545)
7.Secondary Outcome
Title Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Standard Deviation)
Unit of Measure: liters
2474  (461.71) 2321  (419.76)
8.Secondary Outcome
Title Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
1.077  (0.4528) 1.226  (0.4956)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen 40 mg (Period 1), Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 92.04
Confidence Interval (2-Sided) 90%
84.71 to 100.00
Estimation Comments Values have been back-transformed from the log scale.
9.Secondary Outcome
Title Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Time for maximum observed plasma concentration.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the median.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: hours
216
(47.9 to 312)
120
(47.9 to 384)
10.Secondary Outcome
Title Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: hours
207.5  (43.59) 232.5  (56.719)
11.Secondary Outcome
Title Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title 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
Hide 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 - ∞).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 4 7
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
8187  (1688.0) 9329  (2236.8)
14.Secondary Outcome
Title N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
18.30  (3.7576) 24.42  (4.3709)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen 40 mg (Period 1), Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 112.07
Confidence Interval (2-Sided) 90%
107.44 to 116.90
Estimation Comments Values have been back-transformed from the log scale.
15.Secondary Outcome
Title N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Time for maximum observed plasma concentration.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the median.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: hours
35.9
(4.00 to 312)
47.9
(4.00 to 168)
16.Secondary Outcome
Title N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 4 7
Mean (Standard Error)
Unit of Measure: hours
256.0  (24.042) 265.6  (32.082)
17.Secondary Outcome
Title N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title 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
Hide 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 - ∞).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 25 26
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
117.5  (55.433) 133.9  (62.784)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen 40 mg (Period 1), Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 105.60
Confidence Interval (2-Sided) 90%
99.74 to 111.81
Estimation Comments Values have been back-transformed from the log scale.
20.Secondary Outcome
Title 4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
0.6716  (0.1649) 0.7247  (0.1799)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen 40 mg (Period 1), Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Comments DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of adjusted means
Estimated Value 108.47
Confidence Interval (2-Sided) 90%
103.51 to 113.67
Estimation Comments Values have been back-transformed from the log scale.
21.Secondary Outcome
Title 4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Time for maximum observed plasma concentration.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the median.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: hours
6.00
(4.00 to 12.00)
6.00
(3.00 to 23.9)
22.Secondary Outcome
Title 4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description Terminal half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. N=number of participants contributing to the mean.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 25 26
Mean (Standard Error)
Unit of Measure: hours
165.2  (49.699) 177.0  (54.525)
23.Secondary Outcome
Title 4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title 4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population. Data was insufficient for analysis; not analyzable.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR
Hide 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration analysis population: all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: ng/mL
0 hour
NA [1] 
(NA to NA)
1.300
(0.293 to 4.66)
0.5 hour post dose
1.875
(0.000 to 10.3)
4.650
(1.70 to 19.1)
1 hour post dose
11.45
(0.769 to 36.1)
13.90
(3.31 to 47.8)
2 hours post dose
37.20
(2.55 to 74.7)
33.60
(11.0 to 75.2)
3 hours post dose
54.50
(6.57 to 100)
55.60
(17.0 to 99.4)
4 hours post dose
68.25
(26.9 to 95.7)
72.20
(26.6 to 90.7)
6 hours post dose
58.95
(40.1 to 89.3)
60.90
(38.5 to 90.8)
8 hours post dose
54.75
(32.2 to 77.8)
56.10
(33.6 to 73.9)
12 hours post dose
40.40
(21.5 to 61.0)
35.30
(22.8 to 51.7)
16 hours post dose
27.30
(16.4 to 41.6)
26.20
(12.9 to 39.5)
24 hours post dose
24.50
(16.9 to 30.9)
25.50
(12.0 to 39.3)
48 hours post dose
15.40
(7.86 to 22.1)
16.20
(8.36 to 27.1)
72 hours post dose
12.55
(7.28 to 18.8)
12.60
(7.50 to 27.7)
120 hours post dose
10.55
(4.78 to 16.3)
11.60
(5.85 to 21.0)
168 hours post dose
9.120
(3.75 to 13.2)
9.930
(4.83 to 14.9)
216 hours post dose
7.555
(4.10 to 14.0)
8.150
(3.32 to 17.9)
264 hours post dose
7.575
(3.25 to 12.0)
7.270
(2.75 to 13.5)
312 hours post dose
6.445
(2.58 to 12.7)
6.920
(2.85 to 14.3)
384 hours post dose
5.180
(2.18 to 10.4)
5.600
(1.83 to 12.7)
456 hours post dose
4.300
(1.65 to 8.75)
4.330
(1.65 to 9.13)
528 hours post dose
3.560
(1.39 to 8.14)
4.160
(1.03 to 10.9)
[1]
No observations above the lower limit of quantification.
26.Secondary Outcome
Title Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR
Hide 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: ng/mL
0 hour
NA [1] 
(NA to NA)
0.2900
(0.000 to 0.799)
0.5 hour post dose
NA [1] 
(NA to NA)
0.3370
(0.000 to 0.792)
1 hour post dose
NA [1] 
(NA to NA)
0.3430
(0.000 to 1.03)
2 hours post dose
0.0000
(0.000 to 0.126)
0.4100
(0.102 to 1.15)
3 hours post dose
0.0000
(0.000 to 0.275)
0.5020
(0.000 to 1.14)
4 hours post dose
0.1760
(0.000 to 0.590)
0.6350
(0.119 to 1.26)
6 hours post dose
0.2485
(0.000 to 0.516)
0.5870
(0.000 to 1.00)
8 hours post dose
0.2895
(0.102 to 0.624)
0.7310
(0.149 to 1.39)
12 hours post dose
0.4470
(0.116 to 0.884)
0.7310
(0.146 to 1.39)
16 hours post dose
0.4330
(0.111 to 0.818)
0.7130
(0.120 to 1.46)
24 hours post dose
0.6215
(0.162 to 1.05)
0.9900
(0.203 to 1.47)
48 hours post dose
0.9065
(0.150 to 1.40)
1.180
(0.270 to 2.12)
72 hours post dose
0.9740
(0.178 to 1.54)
1.180
(0.208 to 1.83)
120 hours post dose
1.095
(0.135 to 1.89)
1.240
(0.287 to 2.13)
168 hours post dose
1.120
(0.128 to 1.97)
1.140
(0.169 to 2.23)
216 hours post dose
1.120
(0.149 to 1.78)
1.080
(0.193 to 1.80)
264 hours post dose
1.145
(0.166 to 1.57)
1.160
(0.168 to 1.94)
312 hours post dose
1.035
(0.148 to 1.69)
0.9760
(0.157 to 1.86)
384 hours post dose
0.8560
(0.169 to 1.50)
0.9470
(0.121 to 1.61)
456 hours post dose
0.7060
(0.104 to 1.51)
0.9150
(0.119 to 1.37)
528 hours post dose
0.6210
(0.000 to 1.23)
0.7040
(0.000 to 1.47)
[1]
No observations above the lower limit of quantification.
27.Secondary Outcome
Title Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR
Hide 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: ng/mL
0 hour
NA [1] 
(NA to NA)
3.600
(1.22 to 8.84)
0.5 hour post dose
0.0000
(0.000 to 0.465)
4.120
(1.97 to 11.2)
1 hour post dose
0.8050
(0.000 to 3.34)
5.650
(2.64 to 12.4)
2 hours post dose
4.210
(0.310 to 9.46)
9.770
(4.51 to 16.7)
3 hours post dose
9.440
(1.03 to 20.2)
14.80
(6.30 to 26.4)
4 hours post dose
12.55
(2.67 to 20.7)
18.70
(9.09 to 29.9)
6 hours post dose
14.10
(7.61 to 23.3)
19.30
(11.8 to 26.1)
8 hours post dose
14.90
(9.97 to 23.5)
20.40
(14.3 to 30.3)
12 hours post dose
16.10
(10.8 to 26.8)
19.00
(11.1 to 25.7)
16 hours post dose
14.55
(9.14 to 20.1)
18.40
(11.6 to 35.1)
24 hours post dose
16.90
(8.64 to 23.3)
21.90
(12.7 to 32.4)
48 hours post dose
16.45
(9.49 to 23.3)
24.00
(13.3 to 34.9)
72 hours post dose
16.45
(8.01 to 21.8)
19.80
(13.9 to 31.5)
120 hours post dose
15.10
(8.26 to 22.9)
19.80
(15.0 to 31.4)
168 hours post dose
14.40
(8.04 to 26.1)
16.80
(12.7 to 26.3)
216 hours post dose
13.50
(7.75 to 19.6)
15.60
(8.60 to 24.3)
264 hours post dose
12.65
(8.13 to 17.6)
15.40
(5.80 to 22.5)
312 hours post dose
11.40
(6.99 to 18.0)
14.40
(8.39 to 20.6)
384 hours post dose
10.15
(6.46 to 15.5)
13.10
(6.86 to 19.7)
456 hours post dose
8.730
(5.35 to 14.2)
10.50
(3.24 to 16.3)
528 hours post dose
8.730
(4.69 to 13.0)
10.40
(4.36 to 21.7)
[1]
No observations above the lower limit of quantification.
28.Secondary Outcome
Title Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR
Hide 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.
Arm/Group Title Tamoxifen 40 mg (Period 1) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description:
Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
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.
Overall Number of Participants Analyzed 30 29
Median (Full Range)
Unit of Measure: ng/mL
0 hour
NA [1] 
(NA to NA)
0.0000
(0.000 to 0.130)
0.5 hour post dose
NA [1] 
(NA to NA)
0.0000
(0.000 to 0.171)
1 hour post dose
NA [1] 
(NA to NA)
0.0000
(0.000 to 0.321)
2 hours post dose
0.2060
(0.000 to 0.431)
0.2030
(0.000 to 0.633)
3 hours post dose
0.4335
(0.000 to 0.811)
0.3960
(0.136 to 1.00)
4 hours post dose
0.5900
(0.101 to 1.03)
0.6420
(0.232 to 1.13)
6 hours post dose
0.6145
(0.346 to 0.889)
0.7060
(0.340 to 0.985)
8 hours post dose
0.6290
(0.307 to 0.985)
0.7100
(0.408 to 1.06)
12 hours post dose
0.5910
(0.312 to 0.966)
0.5860
(0.354 to 1.07)
16 hours post dose
0.4920
(0.322 to 0.887)
0.5640
(0.308 to 0.947)
24 hours post dose
0.5395
(0.329 to 0.930)
0.5780
(0.300 to 1.02)
48 hours post dose
0.4925
(0.233 to 0.931)
0.4910
(0.235 to 1.12)
72 hours post dose
0.3795
(0.174 to 0.717)
0.4010
(0.200 to 0.903)
120 hours post dose
0.2845
(0.102 to 0.627)
0.2920
(0.171 to 0.745)
168 hours post dose
0.2180
(0.000 to 0.525)
0.2270
(0.107 to 0.548)
216 hours post dose
0.1840
(0.000 to 0.435)
0.1870
(0.000 to 0.423)
264 hours post dose
0.1590
(0.000 to 0.361)
0.1600
(0.000 to 0.367)
312 hours post dose
0.1315
(0.000 to 0.338)
0.1380
(0.000 to 0.323)
384 hours post dose
0.1125
(0.000 to 0.280)
0.1180
(0.000 to 0.286)
456 hours post dose
0.0000
(0.000 to 0.283)
0.0000
(0.000 to 0.208)
528 hours post dose
0.0000
(0.000 to 0.230)
0.0000
(0.000 to 0.296)
[1]
No observations above the lower limit of quantification.
Time Frame Baseline up to Day 36 (follow-up telephone visit)
Adverse Event Reporting 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.
 
Arm/Group Title Tamoxifen 40 mg (Period 1) DVS SR 100 mg (Period 2) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Hide Arm/Group Description Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1. 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. Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
All-Cause Mortality
Tamoxifen 40 mg (Period 1) DVS SR 100 mg (Period 2) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tamoxifen 40 mg (Period 1) DVS SR 100 mg (Period 2) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   0/29 (0.00%)   0/29 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Cholelithiasis  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tamoxifen 40 mg (Period 1) DVS SR 100 mg (Period 2) Tamoxifen 40 mg + DVS SR 100 mg (Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/30 (36.67%)   17/29 (58.62%)   24/29 (82.76%) 
Cardiac disorders       
Palpitations  1  0/30 (0.00%)  0/29 (0.00%)  7/29 (24.14%) 
Eye disorders       
Eye swelling  1  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Vision blurred  1  0/30 (0.00%)  1/29 (3.45%)  1/29 (3.45%) 
Gastrointestinal disorders       
Abdominal pain  1  0/30 (0.00%)  0/29 (0.00%)  3/29 (10.34%) 
Constipation  1  2/30 (6.67%)  6/29 (20.69%)  3/29 (10.34%) 
Diarrhoea  1  1/30 (3.33%)  1/29 (3.45%)  0/29 (0.00%) 
Dry mouth  1  0/30 (0.00%)  1/29 (3.45%)  3/29 (10.34%) 
Dyspepsia  1  0/30 (0.00%)  2/29 (6.90%)  3/29 (10.34%) 
Gastrooesophageal reflux disease  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Nausea  1  0/30 (0.00%)  4/29 (13.79%)  2/29 (6.90%) 
Toothache  1  0/30 (0.00%)  0/29 (0.00%)  3/29 (10.34%) 
Vomiting  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
General disorders       
Chills  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Fatigue  1  1/30 (3.33%)  0/29 (0.00%)  2/29 (6.90%) 
Infections and infestations       
Gastroenteritis viral  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Tooth infection  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Upper respiratory tract infection  1  0/30 (0.00%)  0/29 (0.00%)  4/29 (13.79%) 
Vaginitis bacterial  1  0/30 (0.00%)  1/29 (3.45%)  1/29 (3.45%) 
Investigations       
Blood pressure increased  1  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Weight decreased  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/30 (0.00%)  0/29 (0.00%)  3/29 (10.34%) 
Back pain  1  1/30 (3.33%)  2/29 (6.90%)  3/29 (10.34%) 
Muscle spasms  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Muscle twitching  1  0/30 (0.00%)  1/29 (3.45%)  1/29 (3.45%) 
Musculoskeletal pain  1  2/30 (6.67%)  0/29 (0.00%)  0/29 (0.00%) 
Pain in extremity  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Nervous system disorders       
Balance disorder  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Dizziness  1  0/30 (0.00%)  1/29 (3.45%)  3/29 (10.34%) 
Headache  1  1/30 (3.33%)  1/29 (3.45%)  9/29 (31.03%) 
Hypoaesthesia  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Paraesthesia  1  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Somnolence  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Tremor  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Psychiatric disorders       
Anxiety  1  0/30 (0.00%)  0/29 (0.00%)  3/29 (10.34%) 
Insomnia  1  0/30 (0.00%)  2/29 (6.90%)  8/29 (27.59%) 
Nightmare  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Restlessness  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Renal and urinary disorders       
Dysuria  1  0/30 (0.00%)  0/29 (0.00%)  1/29 (3.45%) 
Reproductive system and breast disorders       
Pelvic pain  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Rhinorrhoea  1  0/30 (0.00%)  1/29 (3.45%)  2/29 (6.90%) 
Skin and subcutaneous tissue disorders       
Erythema  1  0/30 (0.00%)  1/29 (3.45%)  0/29 (0.00%) 
Hyperhidrosis  1  1/30 (3.33%)  0/29 (0.00%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01189500     History of Changes
Other Study ID Numbers: B2061027
3151A1-1206
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: September 9, 2011
Results First Posted: October 17, 2011
Last Update Posted: November 7, 2011