| Primary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) for Empagliflozin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) for empagliflozin. Plasma concentrations and/or parameters of a subject were to be considered as non-evaluable,if for example:
- The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subjects experiencing emesis)
- A predose concentration was >5% Cmax value of that subject
- Missing samples/concentration data at important phases of pharmacokinetic (PK) disposition curve.
Pharmacokinetic parameter set (PKS): This subject set included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was to be included in the PKS even if he/she contributed only one PK parameter value for one period to the statistical assessment. | | Posted | | Geometric Mean | Standard Error | nanomoles*hours/ litres (nmol*h/L) | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
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| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0005656.07± 1.04
- OG0015488.31± 1.04
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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 |
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| The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%. | ANOVA | Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'. | | | Adjusted gmean ratio T/R (%) | 103.06 | Standard Deviation | 5.8 | 2-Sided | 95 | 100.36 | 105.83 | | | The standard deviation is actually intra-individual geometric co-efficient of variation (gCV) | | |
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| Primary | AUC0-tz for Metformin. | | | Posted | | Geometric Mean | Standard Error | nanogram*hours/ millilitres (ng*h/mL) | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Primary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) for Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for Linagliptin | | Posted | | Geometric Mean | Standard Error | nmol*h/L | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
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| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Primary | Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax) | Maximum measured concentration of the empagliflozin in plasma (Cmax) | | Posted | | Geometric Mean | Standard Error | nmol/L | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Primary | Cmax for Metformin in Plasma | Cmax for metformin in plasma. | | Posted | | Geometric Mean | Standard Error | ng/mL | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
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| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Primary | Cmax for Linagliptin in Plasma | Cmax for linagliptin in plasma. | | Posted | | Geometric Mean | Standard Error | nmol/L | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Secondary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Empagliflozin (AUC(0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin (AUC(0-∞) | | Posted | | Geometric Mean | Standard Error | nmol*h/L | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
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| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Secondary | AUC(0-∞) for Metformin | | | Posted | | Geometric Mean | Standard Error | ng*h/mL | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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| Secondary | AUC(0-∞) for Linagliptin | | | Posted | | Geometric Mean | Standard Error | nmol*h/L | | Pharmacokinetic samples were collected at 1:30 hours: minutes 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 hours:minutes post dose | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin/Linagliptin/Metformin FDC (Test) | Subjects were orally administered a single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast | | OG001 | Empagliflozin/Linagliptin/Metformin FC (Reference) | Subjects were orally administered a single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin XR tablets with 240 mL of water after a high-fat, high-calorie breakfast |
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