| Primary | Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz, Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 to the last quantifiable data point is presented. Standard error (SE) is a geometric SE. | Pharmacokinetic parameter set (PKS): PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter that was not excluded due to protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | | Geometric Mean | Standard Error | nanomole*hour/litre (nmol*h/L) | | Pharmacokinetic (PK) samples were collected 1:30 hours:minutes (h:m) pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002134.53± 1.03
- OG0012125.57± 1.03
|
|
| | 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 |
|---|
| An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'. | ANOVA | | <0.0001 | | Adjusted gMean ratio | 100.42 | Standard Error of the Mean | 4.8 | 2-Sided | 90 | 98.17 | 102.72 | | | gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV). | | Equivalence | The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R). |
|
| Primary | Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | AUC0-tz, Area under the concentration-time curve of the metformin in plasma over the time interval from 0 to the last quantifiable data point is presented. Standard error (SE) is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nanogram*h/mL (ng*h/mL) | | Pharmacokinetic (PK) samples were collected 1:30 hours:minutes (h:m) pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Primary | Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (h) (AUC0-72) | AUC0-72, area under the concentration-time curve of the linagliptin in plasma over the time interval from 0 to 72 h is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nmol*h/L | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Primary | Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax) | Cmax, maximum measured concentration of the empagliflozin in plasma is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nanomole/Litre (nmol/ L) | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Primary | Maximum Measured Concentration of the Linagliptin in Plasma (Cmax) | Cmax, maximum measured concentration of the linagliptin in plasma is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nanomole/Litre (nmol/ L) | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Primary | Maximum Measured Concentration of the Metformin in Plasma (Cmax) | Cmax, maximum measured concentration of the metformin in plasma is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nanogram/ millilitre (ng/ mL) | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Secondary | Area Under the Concentration-time Curve of the Empagliflozin Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞, area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nmol*h/L | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Secondary | Area Under the Concentration-time Curve of the Linagliptinin Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞, area under the concentration-time curve of the linagliptin in plasma over the time interval from 0 extrapolated to infinity is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | nmol*h/L | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Secondary | Area Under the Concentration-time Curve of the Metformin Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | AUC0-∞, area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity is presented. SE is a geometric SE. | | Posted | | Geometric Mean | Standard Error | ng*h/mL | | PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |
| Secondary | Percentage of Patients With Drug-related Adverse Events (AEs) | Percentage of patients with investigator defined drug-related AEs are presented. | | Posted | | Number | | Participants | | All adverse events (AEs) which occurred through the treatment phase and throughout the residual effect period (REP), up to 7 days. | | | | ID | Title | Description |
|---|
| OG000 | Test Treatment (T) | Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state. | | OG001 | Reference Treatment (R) | Participants were administered the free combination of 1 film-coated tablet of 10 mg empagliflozin, 1 film-coated tablet of 5 mg linagliptin and 4 film-coated tablets of 500 mg metformin XR orally as single dose in the fed state. |
| |