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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single tablets of empagliflozin and metformin when administered singularly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose, fasted | Experimental | 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions |
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| High dose, fed | Experimental | 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions |
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| Low dose, fasted | Experimental | 2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin/Metformin XR, FDC | Drug | Experimental: high dose empagliflozin/metformin XR, FDC tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin | Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin | AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin | Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin | Cmax (maximum measured concentration of the analyte in plasma); Metformin | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin | AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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Inclusion criteria:
Exclusion criteria:
Any deviation from healthy condition
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1276.13.1 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets | 1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions: 25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet; 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Test Period 1 |
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| Empagliflozin/Metformin XR FDC | Drug | Experimental: low dose empagliflozin/metformin XR, FDC tablet |
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| 25 mg Empagliflozin/1000 mg Metformin XR, FDC | Drug | Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet |
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| 1 tablet Empagliflozin/2 tablets Metformin XR | Drug | Active Comparator: 1x empagliflozin/2x metformin XR tablets |
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| 1 tablet Empagliflozin/3 tablets Metformin XR | Drug | Active Comparator: 1x empagliflozin/3x metformin XR tablets |
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| 1 tablet Empagliflozin/2 tablets Metformin XR | Drug | Active Comparator: 1x empagliflozin/2x metformin XR tablets |
|
| AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin | AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| FG001 | High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet | 3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets; 25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet |
| FG002 | High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets | 1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions: 25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet; 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets |
| FG003 | High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet | 3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets; 25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet |
| FG004 | Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets | 2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions: 12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets; 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets |
| FG005 | Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets | 4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets; 12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets |
| COMPLETED |
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| NOT COMPLETED |
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| Test Period 2 |
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Treated Set (TS): This patient set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose, Fasted | 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions: 25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet; 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets |
| BG001 | High Dose, Fed | 1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions: 25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet; 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets |
| BG002 | Low Dose, Fasted | 2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions: 12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets; 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin | Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin | Pharmacokinetic set (PKS): This set includes all subjects of the Treated set (TS) who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Primary | AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin | AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin | PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Secondary | AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin | AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin | PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Primary | Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin | Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin | PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Primary | Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin | Cmax (maximum measured concentration of the analyte in plasma); Metformin | PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Secondary | AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin | AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin | PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
From first trial medication intake until next intake or the end-of-trial visit, 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose, Fasted: 1 FDC Tablet | 1 fixed dose combination (FDC) tablet under fasted conditions: 25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet | 0 | 23 | 4 | 23 | ||
| EG001 | High Dose, Fasted: 3 Single Tablets | 3 single tablets under fasted conditions: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets | 0 | 23 | 1 | 23 | ||
| EG002 | High Dose, Fed: 1 FDC Tablet | 1 fixed dose combination (FDC) tablet under fed conditions: 25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet | 0 | 24 | 1 | 24 | ||
| EG003 | High Dose, Fed: 3 Single Tablets | 3 single tablets under fed conditions: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets | 0 | 24 | 2 | 24 | ||
| EG004 | Low Dose, Fasted: 2 FDC Tablets | 2 fixed dose combination (FDC) tablets under fasted conditions: 12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets | 0 | 24 | 4 | 24 | ||
| EG005 | Low Dose, Fasted: 4 Single Tablets | 4 single tablets under fed conditions: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets | 0 | 24 | 1 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
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Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Male |
|
| ANOVA | <0.0001 | Adjusted geometric mean ratio (%) | 97.09 | Standard Deviation | 6.7 | 2-Sided | 90 | 93.857 | 100.436 | The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%). | Yes | Non-Inferiority or Equivalence | No formal testing |
| ANOVA | <0.0001 | Adjusted geometric mean ratio (%) | 100.70 | Standard Deviation | 4.9 | 2-Sided | 90 | 98.28 | 103.18 | The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%). | Yes | Non-Inferiority or Equivalence | No formal testing |
| OG003 | High Dose, Fed: 3 Single Tablets | 3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR |
| OG004 | Low Dose, Fasted: 2 FDC Tablets | 2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR |
| OG005 | Low Dose, Fasted: 4 Single Tablets | 4 single tablets, low dose, fasted: 1 x 25 mg tablets Empagliflozin / 3 x 500 mg tablets Metformin XR |
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| OG003 | High Dose, Fed: 3 Single Tablets | 3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR |
| OG004 | Low Dose, Fasted: 2 FDC Tablets | 2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR |
| OG005 | Low Dose, Fasted: 4 Single Tablets | 4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR |
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| High Dose, Fed: 3 Single Tablets |
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR |
| OG004 | Low Dose, Fasted: 2 FDC Tablets | 2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR |
| OG005 | Low Dose, Fasted: 4 Single Tablets | 4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR |
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3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR |
| OG004 | Low Dose, Fasted: 2 FDC Tablets | 2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR |
| OG005 | Low Dose, Fasted: 4 Single Tablets | 4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR |
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| OG003 | High Dose, Fed: 3 Single Tablets | 3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR |
| OG004 | Low Dose, Fasted: 2 FDC Tablets | 2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR |
| OG005 | Low Dose, Fasted: 4 Single Tablets | 4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR |
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