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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 combinations (FDC) tablets containing empagliflozin & metformin XR and the single tablets of empagliflozin and metformin XR 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 dose combination (FDC) tablets vs 4 single tablets under fasted conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 tablet Empagliflozin/2 tablets Metformin XR | Drug | Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin | Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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, for Empagliflozin | Maximum measured concentration of empagliflozin in plasma (Cmax). | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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, for Metformin | Maximum measured concentration of metformin in plasma | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 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 |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 10 mg Empagliflozin/1000 mg Metformin XR | Drug | Experimental: high dose Empagliflozin/Metformin XR, FDC tablet |
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| 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR | Drug | Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets |
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| 2 tablets 5 mg Empagliflozin/750 Metformin XR | Drug | Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets |
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| 1 tablet Empagliflozin/2 tablets Metformin XR | Drug | Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets |
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| 10 mg Empagliflozin/1000 mg Metformin XR | Drug | Experimental: high dose Empagliflozin/Metformin XR, FDC tablet |
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| AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin | Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| FG001 |
| Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted) |
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h. |
| FG002 | Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal. |
| FG003 | Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal. |
| FG004 | Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h. |
| FG005 | Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h. |
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| NOT COMPLETED |
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Treated set which included 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 | 1000mg, Fasted | Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h). |
| BG001 | 1000mg, Fed | Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal |
| BG002 | 1500mg, Fasted | Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h |
| 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 |
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| Sex: Female, Male | 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 | AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). | Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK 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, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Primary | AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin | Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point | Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK 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, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Secondary | AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). | Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK 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, 2.5h, 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, for Empagliflozin | Maximum measured concentration of empagliflozin in plasma (Cmax). | Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK 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, 2.5h, 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, for Metformin | Maximum measured concentration of metformin in plasma | Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK 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, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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| Secondary | AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin | Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity | Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK 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, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
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From drug administration until next treatment period or follow-up 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 | Empa/1000 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | 0 | 24 | 4 | 24 | ||
| EG001 | Empa/ 1000 mg Met FDC (Fasted) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | 0 | 24 | 5 | 24 | ||
| EG002 | Empa/1000 mg Glumetza ® (Fed) | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | 0 | 24 | 4 | 24 | ||
| EG003 | Empa/ 1000 mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | 0 | 24 | 4 | 24 | ||
| EG004 | Empa/ 1500 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | 0 | 24 | 6 | 24 | ||
| EG005 | Empa/ 1500 mg Met FDC (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h | 0 | 23 | 7 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 17.0 | Systematic Assessment |
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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 |
| Male |
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| ANOVA | P-value for ratio outside interval 80%-125% | <0.0001 | Adjusted geometric mean ratio (%) | 100.25 | Standard Error of the Mean | 1.021 | 2-Sided | 90 | 96.809 | 103.823 | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | Non-Inferiority or Equivalence | Model includes effects for sequence, subjects within sequences, period and treatment. |
| ANOVA | P-value for ratio outside interval 80%-125% | <0.0001 | Adjusted geometric mean ratio (%) | 96.08 | Standard Error of the Mean | 1.016 | 2-Sided | 90 | 93.507 | 98.721 | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | Non-Inferiority or Equivalence | Model includes effects for sequence, subjects within sequences, period and treatment. |
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
| OG003 | Empa/ 1000 mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal |
| OG004 | Empa/ 1500 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h |
| OG005 | Empa/ 1500 mg Met FDC (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
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Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
| OG003 | Empa/ 1000 mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal |
| OG004 | Empa/ 1500 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h |
| OG005 | Empa/ 1500 mg Met FDC (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
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| OG003 | Empa/ 1000 mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal |
| OG004 | Empa/ 1500 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h |
| OG005 | Empa/ 1500 mg Met FDC (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
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| OG003 | Empa/ 1000 mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal |
| OG004 | Empa/ 1500 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h |
| OG005 | Empa/ 1500 mg Met FDC (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
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Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
| OG003 | Empa/ 1000 mg Met FDC (Fed) | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal |
| OG004 | Empa/ 1500 mg Glumetza® (Fasted) | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h |
| OG005 | Empa/ 1500 mg Met FDC (Fasted) | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
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