| Primary | Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000436± 14.1
- OG0011090± 29.2
|
|
| |
| Primary | Time to Maximum Measured Concentration (Tmax) | Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1 | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Terminal Rate Constant (λz) | Terminal Rate Constant in Plasma (λz), after the first dose on day 1 | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/h | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Terminal Half-life (t1/2) | Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1 | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Mean Residence Time (MRTpo) | Mean residence time of empagliflozin (empa) in the body after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F) | Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Apparent Volume of Distribution During the Terminal Phase λz (Vz/F) | Apparent volume of distribution during the terminal phase λz, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24) | Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol | | Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24). | Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of empa | | Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Renal Clearance After Extravascular Administration (CL R,0-48) | Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet. |
| |
| Primary | Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss) | Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss) | Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss) | Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Terminal Rate Constant in Plasma at Steady State (λz,ss) | Terminal rate constant in plasma at steady state, after multiple dosing. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 1/h | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Terminal Half-life in Plasma at Steady State (t1/2,ss) | Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Mean Residence Time at Steady State (MRTpo,ss) | Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss) | Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss) | Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss) | Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol | | Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss) | Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of empa | | Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Renal Clearance at Steady State (CL R,ss) | Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Accumulation Ratio Based on AUC (R A,AUC) | Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Accumulation Ratio Based on Cmax (R A,Cmax) | Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9 | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG001 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Predose Plasma Concentration Before Planned Dose x (Cpre,x) | Predose plasma concentration of empagliflozin (empa) before planned dose by day. This endpoint in steady state is identical to Cmin,ss. | Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 5 minutes before drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa 10 mg | A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet. | | OG001 | Empa 25 mg | A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet. |
| |
| Secondary | Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference | Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference. Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint. | Treated set (TS) includes all patients who were documented to have taken at least one dose of investigational treatment. | Posted | | Number | | participants | | Drug administration until end of trial, up to 21 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). | | OG001 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration. | | OG002 | Empa 25 mg | |
|
| Primary | Urinary Glucose Excretion (UGE) Change From Baseline | Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point. | Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint. | Posted | | Mean | Standard Deviation | mg | | Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days. | | OG001 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG002 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
| |
| Primary | Fasting Plasma Glucose (FPG) Change From Baseline | Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9. | Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint. | Posted | | Mean | Standard Deviation | mg/dL | | Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration | | | | ID | Title | Description |
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| OG000 | Placebo | Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days. | | OG001 | Empa 10 mg | 10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration. | | OG002 | Empa 25 mg | 25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration. |
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