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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005156-42 | EudraCT Number | EudraCT |
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Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Empagliflozin/Metformin (T) | Experimental | fixed-dose-combination tablet, oral with 240 ml water under fasted conditions |
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| 2 Empagliflozin/Metformin (T) | Experimental | fixed-dose-combination tablet, oral with 240 ml water under fed conditions |
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| 3 Empagliflozin + Metformin (R) | Experimental | tablets, oral with 240 ml water under fasted conditions |
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| 4 Empagliflozin + Metformin (R) | Experimental | tablets, oral with 240 ml water under fed conditions |
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| 5 Empagliflozin/Metformin (T) | Experimental | fixed-dose-combination tablet, oral with 240 ml water under fed conditions |
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| 6 Empagliflozin + Metformin (R) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | medium dose oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin | AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin | AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin | Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Maximum Measured Concentration of the Analyte in Plasma, Metformin | Cmax: maximum measured concentration of the analyte in plasma for Metformin | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| 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, Empagliflozin | 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 | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1276.8.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed | fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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tablets, oral with 240 ml water under fed conditions |
|
| Metformin |
| Drug |
oral administration |
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| Empagliflozin | Drug | low dose of Empagliflozin oral administration |
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| Empagliflozin/Metformin | Drug | low dose of Empagliflozin |
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| Metformin | Drug | oral administration |
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| Empagliflozin/Metformin | Drug | medium dose of Empagliflozin oral administration |
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| Empagliflozin | Drug | medium dose oral administration |
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| Metformin | Drug | oral administration |
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| Empagliflozin/Metformin | Drug | medium dose of Empagliflozin oral administration |
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| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin | 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 | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| FG001 |
| Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted |
fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| FG002 | Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed | free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| FG003 | Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted | free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| FG004 | Low Dose Emp: Emp/Met / Emp+Met | fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| FG005 | Low Dose Emp: Emp+Met / Emp/Met | free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| COMPLETED |
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| NOT COMPLETED |
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Treated Set (TS): includes all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed | fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| BG001 | Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted | fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| BG002 | Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed | free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| BG003 | Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted | free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| BG004 | Low Dose Emp: Emp/Met / Emp+Met | fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| BG005 | Low Dose Emp: Emp+Met / Emp/Met | free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin | AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin | Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Primary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin | AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin | PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin | 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 | PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Primary | Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin | Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin | PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Primary | Maximum Measured Concentration of the Analyte in Plasma, Metformin | Cmax: maximum measured concentration of the analyte in plasma for Metformin | PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin | 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 | PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
|
From first trial medication intake until next intake or the end-of-trial visit, 10 days
Adverse Evens were reported for all patients who received the specific treatment.
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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 | 1 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration | 0 | 23 | 6 | 23 | ||
| EG001 | 2 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration | 0 | 24 | 6 | 24 | ||
| EG002 | 3 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration | 0 | 24 | 4 | 24 | ||
| EG003 | 4 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration | 0 | 24 | 6 | 24 | ||
| EG004 | 5 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin | 0 | 23 | 9 | 23 | ||
| EG005 | 6 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration | 0 | 23 | 10 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
|
| ANOVA | <0.0001 | Geometric mean ratio | 98.88 | Standard Error of the Mean | 1.024 | 2-Sided | 90 | 94.879 | 103.059 | The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'. | Yes | Non-Inferiority or Equivalence | The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%. |
| ANOVA | <0.0001 | Geometric mean ratio | 106.00 | Standard Error of the Mean | 1.018 | 2-Sided | 90 | 102.728 | 109.386 | The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'. | Yes | Non-Inferiority or Equivalence | The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%. |
| OG003 | 4 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration |
| OG004 | 5 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin |
| OG005 | 6 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration |
|
|
|
tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration
| OG003 | 4 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration |
| OG004 | 5 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin |
| OG005 | 6 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration |
|
|
|
| OG003 | 4 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration |
| OG004 | 5 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin |
| OG005 | 6 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration |
|
|
|
| OG003 | 4 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration |
| OG004 | 5 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin |
| OG005 | 6 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration |
|
|
|
tablets, oral with 240 ml water under fasted conditions
Empagliflozin: medium dose oral administration
Metformin: oral administration
| OG003 | 4 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration |
| OG004 | 5 Empagliflozin/Metformin (T) | fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin |
| OG005 | 6 Empagliflozin + Metformin (R) | tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration |
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