| Primary | 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 | 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). | 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. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005751± 1540.1
- OG0015888± 1905.5
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference) | | | | | ratio of adjusted means | 100.69 | | | 2-Sided | 90 | 96.70 | 104.85 | | | Values have been back-transformed from the log scale. | No | Superiority or Other | | |
|
| Primary | 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 | 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 - ∞). | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR | Cmax measured as nanograms per milliliters (ng/mL). | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR | Time for maximum observed plasma concentration. | PK parameter analysis population. N=number of participants contributing to the median. | Posted | | Median | Full Range | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR | Terminal half-life is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Mean | Standard Deviation | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR | 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). | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | mL/min | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR | Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant. | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | liters | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR | | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR | Time for maximum observed plasma concentration. | PK parameter analysis population. N=number of participants contributing to the median. | Posted | | Median | Full Range | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR | Terminal half-life is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Mean | Standard Deviation | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR | 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). | PK parameter analysis population. Data was insufficient for analysis; not analyzable. | Posted | | Geometric Mean | Standard Deviation | mL/min | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR | | PK parameter analysis population. Data was insufficient for analysis; not analyzable. | Posted | | Geometric Mean | Standard Deviation | liters | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 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 | 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 - ∞). | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR | | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR | Time for maximum observed plasma concentration. | PK parameter analysis population. N=number of participants contributing to the median. | Posted | | Median | Full Range | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR | Terminal half-life is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Mean | Standard Error | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR | 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). | PK parameter analysis population. Data was insufficient for analysis; not analyzable. | Posted | | Geometric Mean | Standard Deviation | mL/min | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR | | PK parameter analysis population. Data was insufficient for analysis; not analyzable. | Posted | | Geometric Mean | Standard Deviation | liters | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 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 | 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 - ∞). | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng*hr/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR | | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR | Time for maximum observed plasma concentration. | PK parameter analysis population. N=number of participants contributing to the median. | Posted | | Median | Full Range | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR | Terminal half-life is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population. N=number of participants contributing to the mean. | Posted | | Mean | Standard Error | hours | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR | 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). | PK parameter analysis population. Data was insufficient for analysis; not analyzable. | Posted | | Geometric Mean | Standard Deviation | mL/min | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
| |
| Secondary | 4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR | | PK parameter analysis population. Data was insufficient for analysis; not analyzable. | Posted | | Geometric Mean | Standard Deviation | liters | | 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. | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
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| Secondary | Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR | 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. | 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. | Posted | | Median | Full Range | ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
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| Secondary | Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR | 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. | 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. | Posted | | Median | Full Range | ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
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| Secondary | Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR | 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. | 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. | Posted | | Median | Full Range | ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
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| Secondary | Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR | 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. | 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. | Posted | | Median | Full Range | ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Tamoxifen 40 mg (Period 1) | Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. | | OG001 | Tamoxifen 40 mg + DVS SR 100 mg (Period 2) | 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. |
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