Trial Outcomes & Findings for 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 (NCT NCT01189500)

Last Updated: 2011-11-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome 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.

Results posted on

2011-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg 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 1: TAMOX Alone STARTED	30
Period 1: TAMOX Alone COMPLETED	29
Period 1: TAMOX Alone NOT COMPLETED	1
Period 2: Coadministration TAMOX+DVS SR STARTED	29
Period 2: Coadministration TAMOX+DVS SR COMPLETED	28
Period 2: Coadministration TAMOX+DVS SR NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg 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 1: TAMOX Alone Adverse Event	1
Period 2: Coadministration TAMOX+DVS SR Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg n=30 Participants 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.
Age, Customized 45 to 64 years	27 participants n=5 Participants
Age, Customized ≥65 years	3 participants n=5 Participants
Sex/Gender, Customized	30 participants n=5 Participants

PRIMARY outcome

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.

Population: 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.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=26 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=26 Participants 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.
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	5751 ng*hr/mL Standard Deviation 1540.1	5888 ng*hr/mL Standard Deviation 1905.5

PRIMARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

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 - ∞).

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=4 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=4 Participants 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.
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	677.7 ng*hr/mL Standard Deviation 200.42	505.6 ng*hr/mL Standard Deviation 220.87

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Cmax measured as nanograms per milliliters (ng/mL).

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR	70.58 ng/mL Standard Deviation 16.310	70.33 ng/mL Standard Deviation 14.484

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the median.

Time for maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR	4.00 hours Interval 3.0 to 8.0	4.00 hours Interval 3.0 to 8.0

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=26 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=26 Participants 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.
Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR	250.5 hours Standard Deviation 44.410	242.3 hours Standard Deviation 51.851

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

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).

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=26 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=26 Participants 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.
Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR	115.9 mL/min Standard Deviation 34.544	113.2 mL/min Standard Deviation 44.545

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Calculated as Dose / (AUCinf \* kel); where kel=terminal phase rate constant.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=26 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=26 Participants 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.
Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR	2474 liters Standard Deviation 461.71	2321 liters Standard Deviation 419.76

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR	1.077 ng/mL Standard Deviation 0.4528	1.226 ng/mL Standard Deviation 0.4956

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the median.

Time for maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR	216 hours Interval 47.9 to 312.0	120 hours Interval 47.9 to 384.0

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=4 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=4 Participants 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.
Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR	207.5 hours Standard Deviation 43.59	232.5 hours Standard Deviation 56.719

SECONDARY outcome

Population: PK parameter analysis population. Data was insufficient for analysis; not analyzable.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK parameter analysis population. Data was insufficient for analysis; not analyzable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

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 - ∞).

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=4 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=7 Participants 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.
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	8187 ng*hr/mL Standard Deviation 1688.0	9329 ng*hr/mL Standard Deviation 2236.8

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR	18.30 ng/mL Standard Deviation 3.7576	24.42 ng/mL Standard Deviation 4.3709

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the median.

Time for maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR	35.9 hours Interval 4.0 to 312.0	47.9 hours Interval 4.0 to 168.0

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=4 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=7 Participants 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.
N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR	256.0 hours Standard Error 24.042	265.6 hours Standard Error 32.082

SECONDARY outcome

Population: PK parameter analysis population. Data was insufficient for analysis; not analyzable.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK parameter analysis population. Data was insufficient for analysis; not analyzable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

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 - ∞).

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=25 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=26 Participants 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.
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	117.5 ng*hr/mL Standard Deviation 55.433	133.9 ng*hr/mL Standard Deviation 62.784

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR	0.6716 ng/mL Standard Deviation 0.1649	0.7247 ng/mL Standard Deviation 0.1799

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the median.

Time for maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR	6.00 hours Interval 4.0 to 12.0	6.00 hours Interval 3.0 to 23.9

SECONDARY outcome

Population: PK parameter analysis population. N=number of participants contributing to the mean.

Terminal half-life is the time measured for the plasma concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=25 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=26 Participants 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.
4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR	165.2 hours Standard Error 49.699	177.0 hours Standard Error 54.525

SECONDARY outcome

Population: PK parameter analysis population. Data was insufficient for analysis; not analyzable.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK parameter analysis population. Data was insufficient for analysis; not analyzable.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0.5 hour post dose	1.875 ng/mL Interval 0.0 to 10.3	4.650 ng/mL Interval 1.7 to 19.1
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 216 hours post dose	7.555 ng/mL Interval 4.1 to 14.0	8.150 ng/mL Interval 3.32 to 17.9
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 264 hours post dose	7.575 ng/mL Interval 3.25 to 12.0	7.270 ng/mL Interval 2.75 to 13.5
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0 hour	NA ng/mL No observations above the lower limit of quantification.	1.300 ng/mL Interval 0.293 to 4.66
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 1 hour post dose	11.45 ng/mL Interval 0.769 to 36.1	13.90 ng/mL Interval 3.31 to 47.8
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 2 hours post dose	37.20 ng/mL Interval 2.55 to 74.7	33.60 ng/mL Interval 11.0 to 75.2
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 3 hours post dose	54.50 ng/mL Interval 6.57 to 100.0	55.60 ng/mL Interval 17.0 to 99.4
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 4 hours post dose	68.25 ng/mL Interval 26.9 to 95.7	72.20 ng/mL Interval 26.6 to 90.7
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 6 hours post dose	58.95 ng/mL Interval 40.1 to 89.3	60.90 ng/mL Interval 38.5 to 90.8
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 8 hours post dose	54.75 ng/mL Interval 32.2 to 77.8	56.10 ng/mL Interval 33.6 to 73.9
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 12 hours post dose	40.40 ng/mL Interval 21.5 to 61.0	35.30 ng/mL Interval 22.8 to 51.7
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 16 hours post dose	27.30 ng/mL Interval 16.4 to 41.6	26.20 ng/mL Interval 12.9 to 39.5
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 24 hours post dose	24.50 ng/mL Interval 16.9 to 30.9	25.50 ng/mL Interval 12.0 to 39.3
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 48 hours post dose	15.40 ng/mL Interval 7.86 to 22.1	16.20 ng/mL Interval 8.36 to 27.1
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 72 hours post dose	12.55 ng/mL Interval 7.28 to 18.8	12.60 ng/mL Interval 7.5 to 27.7
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 120 hours post dose	10.55 ng/mL Interval 4.78 to 16.3	11.60 ng/mL Interval 5.85 to 21.0
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 168 hours post dose	9.120 ng/mL Interval 3.75 to 13.2	9.930 ng/mL Interval 4.83 to 14.9
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 312 hours post dose	6.445 ng/mL Interval 2.58 to 12.7	6.920 ng/mL Interval 2.85 to 14.3
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 384 hours post dose	5.180 ng/mL Interval 2.18 to 10.4	5.600 ng/mL Interval 1.83 to 12.7
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 456 hours post dose	4.300 ng/mL Interval 1.65 to 8.75	4.330 ng/mL Interval 1.65 to 9.13
Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 528 hours post dose	3.560 ng/mL Interval 1.39 to 8.14	4.160 ng/mL Interval 1.03 to 10.9

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0 hour	NA ng/mL No observations above the lower limit of quantification.	0.2900 ng/mL Interval 0.0 to 0.799
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 1 hour post dose	NA ng/mL No observations above the lower limit of quantification.	0.3430 ng/mL Interval 0.0 to 1.03
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 2 hours post dose	0.0000 ng/mL Interval 0.0 to 0.126	0.4100 ng/mL Interval 0.102 to 1.15
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 12 hours post dose	0.4470 ng/mL Interval 0.116 to 0.884	0.7310 ng/mL Interval 0.146 to 1.39
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 72 hours post dose	0.9740 ng/mL Interval 0.178 to 1.54	1.180 ng/mL Interval 0.208 to 1.83
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0.5 hour post dose	NA ng/mL No observations above the lower limit of quantification.	0.3370 ng/mL Interval 0.0 to 0.792
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 3 hours post dose	0.0000 ng/mL Interval 0.0 to 0.275	0.5020 ng/mL Interval 0.0 to 1.14
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 4 hours post dose	0.1760 ng/mL Interval 0.0 to 0.59	0.6350 ng/mL Interval 0.119 to 1.26
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 6 hours post dose	0.2485 ng/mL Interval 0.0 to 0.516	0.5870 ng/mL Interval 0.0 to 1.0
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 8 hours post dose	0.2895 ng/mL Interval 0.102 to 0.624	0.7310 ng/mL Interval 0.149 to 1.39
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 16 hours post dose	0.4330 ng/mL Interval 0.111 to 0.818	0.7130 ng/mL Interval 0.12 to 1.46
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 24 hours post dose	0.6215 ng/mL Interval 0.162 to 1.05	0.9900 ng/mL Interval 0.203 to 1.47
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 48 hours post dose	0.9065 ng/mL Interval 0.15 to 1.4	1.180 ng/mL Interval 0.27 to 2.12
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 120 hours post dose	1.095 ng/mL Interval 0.135 to 1.89	1.240 ng/mL Interval 0.287 to 2.13
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 168 hours post dose	1.120 ng/mL Interval 0.128 to 1.97	1.140 ng/mL Interval 0.169 to 2.23
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 216 hours post dose	1.120 ng/mL Interval 0.149 to 1.78	1.080 ng/mL Interval 0.193 to 1.8
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 264 hours post dose	1.145 ng/mL Interval 0.166 to 1.57	1.160 ng/mL Interval 0.168 to 1.94
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 312 hours post dose	1.035 ng/mL Interval 0.148 to 1.69	0.9760 ng/mL Interval 0.157 to 1.86
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 384 hours post dose	0.8560 ng/mL Interval 0.169 to 1.5	0.9470 ng/mL Interval 0.121 to 1.61
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 456 hours post dose	0.7060 ng/mL Interval 0.104 to 1.51	0.9150 ng/mL Interval 0.119 to 1.37
Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 528 hours post dose	0.6210 ng/mL Interval 0.0 to 1.23	0.7040 ng/mL Interval 0.0 to 1.47

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0.5 hour post dose	0.0000 ng/mL Interval 0.0 to 0.465	4.120 ng/mL Interval 1.97 to 11.2
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 1 hour post dose	0.8050 ng/mL Interval 0.0 to 3.34	5.650 ng/mL Interval 2.64 to 12.4
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 8 hours post dose	14.90 ng/mL Interval 9.97 to 23.5	20.40 ng/mL Interval 14.3 to 30.3
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 72 hours post dose	16.45 ng/mL Interval 8.01 to 21.8	19.80 ng/mL Interval 13.9 to 31.5
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 216 hours post dose	13.50 ng/mL Interval 7.75 to 19.6	15.60 ng/mL Interval 8.6 to 24.3
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 264 hours post dose	12.65 ng/mL Interval 8.13 to 17.6	15.40 ng/mL Interval 5.8 to 22.5
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0 hour	NA ng/mL No observations above the lower limit of quantification.	3.600 ng/mL Interval 1.22 to 8.84
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 2 hours post dose	4.210 ng/mL Interval 0.31 to 9.46	9.770 ng/mL Interval 4.51 to 16.7
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 3 hours post dose	9.440 ng/mL Interval 1.03 to 20.2	14.80 ng/mL Interval 6.3 to 26.4
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 4 hours post dose	12.55 ng/mL Interval 2.67 to 20.7	18.70 ng/mL Interval 9.09 to 29.9
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 6 hours post dose	14.10 ng/mL Interval 7.61 to 23.3	19.30 ng/mL Interval 11.8 to 26.1
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 12 hours post dose	16.10 ng/mL Interval 10.8 to 26.8	19.00 ng/mL Interval 11.1 to 25.7
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 16 hours post dose	14.55 ng/mL Interval 9.14 to 20.1	18.40 ng/mL Interval 11.6 to 35.1
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 24 hours post dose	16.90 ng/mL Interval 8.64 to 23.3	21.90 ng/mL Interval 12.7 to 32.4
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 48 hours post dose	16.45 ng/mL Interval 9.49 to 23.3	24.00 ng/mL Interval 13.3 to 34.9
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 120 hours post dose	15.10 ng/mL Interval 8.26 to 22.9	19.80 ng/mL Interval 15.0 to 31.4
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 168 hours post dose	14.40 ng/mL Interval 8.04 to 26.1	16.80 ng/mL Interval 12.7 to 26.3
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 312 hours post dose	11.40 ng/mL Interval 6.99 to 18.0	14.40 ng/mL Interval 8.39 to 20.6
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 384 hours post dose	10.15 ng/mL Interval 6.46 to 15.5	13.10 ng/mL Interval 6.86 to 19.7
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 456 hours post dose	8.730 ng/mL Interval 5.35 to 14.2	10.50 ng/mL Interval 3.24 to 16.3
Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 528 hours post dose	8.730 ng/mL Interval 4.69 to 13.0	10.40 ng/mL Interval 4.36 to 21.7

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Tamoxifen 40 mg (Period 1) n=30 Participants Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.	Tamoxifen 40 mg + DVS SR 100 mg (Period 2) n=29 Participants 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.
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0.5 hour post dose	NA ng/mL No observations above the lower limit of quantification.	0.0000 ng/mL Interval 0.0 to 0.171
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 1 hour post dose	NA ng/mL No observations above the lower limit of quantification.	0.0000 ng/mL Interval 0.0 to 0.321
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 4 hours post dose	0.5900 ng/mL Interval 0.101 to 1.03	0.6420 ng/mL Interval 0.232 to 1.13
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 72 hours post dose	0.3795 ng/mL Interval 0.174 to 0.717	0.4010 ng/mL Interval 0.2 to 0.903
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 120 hours post dose	0.2845 ng/mL Interval 0.102 to 0.627	0.2920 ng/mL Interval 0.171 to 0.745
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 528 hours post dose	0.0000 ng/mL Interval 0.0 to 0.23	0.0000 ng/mL Interval 0.0 to 0.296
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 0 hour	NA ng/mL No observations above the lower limit of quantification.	0.0000 ng/mL Interval 0.0 to 0.13
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 2 hours post dose	0.2060 ng/mL Interval 0.0 to 0.431	0.2030 ng/mL Interval 0.0 to 0.633
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 3 hours post dose	0.4335 ng/mL Interval 0.0 to 0.811	0.3960 ng/mL Interval 0.136 to 1.0
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 6 hours post dose	0.6145 ng/mL Interval 0.346 to 0.889	0.7060 ng/mL Interval 0.34 to 0.985
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 8 hours post dose	0.6290 ng/mL Interval 0.307 to 0.985	0.7100 ng/mL Interval 0.408 to 1.06
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 12 hours post dose	0.5910 ng/mL Interval 0.312 to 0.966	0.5860 ng/mL Interval 0.354 to 1.07
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 16 hours post dose	0.4920 ng/mL Interval 0.322 to 0.887	0.5640 ng/mL Interval 0.308 to 0.947
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 24 hours post dose	0.5395 ng/mL Interval 0.329 to 0.93	0.5780 ng/mL Interval 0.3 to 1.02
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 48 hours post dose	0.4925 ng/mL Interval 0.233 to 0.931	0.4910 ng/mL Interval 0.235 to 1.12
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 168 hours post dose	0.2180 ng/mL Interval 0.0 to 0.525	0.2270 ng/mL Interval 0.107 to 0.548
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 216 hours post dose	0.1840 ng/mL Interval 0.0 to 0.435	0.1870 ng/mL Interval 0.0 to 0.423
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 264 hours post dose	0.1590 ng/mL Interval 0.0 to 0.361	0.1600 ng/mL Interval 0.0 to 0.367
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 312 hours post dose	0.1315 ng/mL Interval 0.0 to 0.338	0.1380 ng/mL Interval 0.0 to 0.323
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 384 hours post dose	0.1125 ng/mL Interval 0.0 to 0.28	0.1180 ng/mL Interval 0.0 to 0.286
Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR 456 hours post dose	0.0000 ng/mL Interval 0.0 to 0.283	0.0000 ng/mL Interval 0.0 to 0.208

Adverse Events

Tamoxifen 40 mg (Period 1)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

DVS SR 100 mg (Period 2)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Tamoxifen 40 mg + DVS SR 100 mg (Period 2)

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tamoxifen 40 mg (Period 1) n=30 participants at risk Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1.	DVS SR 100 mg (Period 2) n=29 participants at risk 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 + DVS SR 100 mg (Period 2) n=29 participants at risk Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
Hepatobiliary disorders Cholecystitis	3.3% 1/30 • Baseline up to Day 36 (follow-up telephone visit) 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.	0.00% 0/29 • Baseline up to Day 36 (follow-up telephone visit) 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.	0.00% 0/29 • Baseline up to Day 36 (follow-up telephone visit) 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.
Hepatobiliary disorders Cholelithiasis	3.3% 1/30 • Baseline up to Day 36 (follow-up telephone visit) 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.	0.00% 0/29 • Baseline up to Day 36 (follow-up telephone visit) 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.	0.00% 0/29 • Baseline up to Day 36 (follow-up telephone visit) 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.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER