| Primary | Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0005990± 21.0
- OG0015720± 20.8
|
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| | 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 |
|---|
| No formal testing, investigation of relative bioavailability | ANOVA | Based on ANOVA with terms for sequence, subjects within sequence, period and treatment | | | Geometric Mean Ratio | 104.90 | Standard Deviation | 7.2 | 2-Sided | 90 | 102.07 | 107.80 | | | Standard deviation is actually the geometric coefficient of variation (gCV) | Yes | Non-Inferiority or Equivalence | Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted) |
|
| Primary | Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72) | Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together |
| |
| Primary | Empagliflozin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together |
| |
| Primary | Linagliptin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together |
| |
| Secondary | Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax) | Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Median | Full Range | hours | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together | | OG002 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. | |
|
| Secondary | Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax) | Time from last dosing to the maximum measured concentration of linagliptin in plasma | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Median | Full Range | hours | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together | | OG002 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. | | OG003 |
|
| Secondary | Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together |
| |
| Secondary | Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Individual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together |
| |
| Secondary | Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
| |
| Primary | Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
| |
| Primary | Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
| |
| Secondary | Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
| |
| Primary | Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax) | Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
| |
| Primary | Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72) | Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
| |
| Secondary | Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A3 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3). |
| |
| Primary | Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A3 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3. |
| |
| Primary | Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A3 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3. |
| |
| Secondary | Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A3 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3). |
| |
| Primary | Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax) | Maximum measured concentration of linagliptin in plasma. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A3 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3). |
| |
| Primary | Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72) | Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours. In this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin FDC A3 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3). |
| |
| Secondary | Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator | Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination. | Treated set (TS) included all subjects who were documented to have taken at least one dose of investigational treatment. | Posted | | Number | | participants | | Drug administration until next treatment period/end-of-study examination, up to 36 days | | | | ID | Title | Description |
|---|
| OG000 | Empa Plus Linagliptin FDC A1 (Fasted) | A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) | | OG001 | Empa Plus Linagliptin Indivdual Tablets (Fasted) | Individual tablets of empa 25 mg and linagliptin 5 mg administered together | | OG002 | Empa Plus Linagliptin FDC A1 (Fed) | A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. |
|