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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018589-22 | EudraCT Number | EudraCT |
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The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 3 treatments will be investigated in randomized order |
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| B | Experimental | 3 treatments will be investigated in randomized order |
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| C | Experimental | 3 treatments will be investigated in randomized order |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C: BI 10773 / metformin tablet | Drug | BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal |
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| Measure | Description | Time Frame |
|---|---|---|
| Empa: 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. Note the standard deviation is actually the coefficient of variation (CV). | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Metformin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Metformin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1276.5.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
An open label, randomised, three-way crossover study. A washout period of at least 7 days was respected between drug administrations.
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| ID | Title | Description |
|---|---|---|
| FG000 | FDC Fasted / Individual Tablets Fasted / FDC Fed | Patients received the three treatments in the following order:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (1 Day) |
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| B: BI 10773 tablet and metformin tablet | Drug | BI 10773 and metformin single tablets, administered together in fasted state |
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| A: BI 10773 / metformin tablet | Drug | BI 10773 / metformin fixed dose combination tablet in fasted state |
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| Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Time to Maximum Measured Concentration (Tmax) | Time from dosing to the maximum concentration of the analyte in plasma. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Terminal Elimination Rate Constant in Plasma (λz) | Terminal elimination rate constant in plasma. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Terminal Half-life in Plasma (T1/2) | Terminal half-life of the analyte in plasma. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Mean Residence Time in the Body After Oral Administration (MRTpo) | Mean residence time of the analyte in the body after oral administration. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Apparent Clearance After Extravascular Administration (CL/F) | Apparent clearance of the analyte in the plasma after extravascular administration. Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) | Apparent volume of distribution during the terminal phase (λz). Note the standard deviation is actually the CV. | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| 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. | Drug administration up to 7 days after last drug administration, up to 8 days |
| FG001 | FDC Fasted / FDC Fed / Individual Tablets Fasted | Patients received the three treatments in the following order:
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| FG002 | Individual Tablets Fasted / FDC Fasted / FDC Fed | Patients received the three treatments in the following order:
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| FG003 | Individual Tablets Fasted / FDC Fed / FDC Fasted | Patients received the three treatments in the following order:
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| FG004 | FDC Fed / FDC Fasted / Individual Tablets Fasted | Patients received the three treatments in the following order:
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| FG005 | FDC Fed / Individual Tablets Fasted / FDC Fasted | Patients received the three treatments in the following order:
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| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 (7 Days) |
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| Treatment Period 2 (1 Day) |
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| Washout Period 2 (7 Days) |
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| Treatment Period 3 (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | An open label, randomised, three-way crossover study. The three treatments administered were
A washout period of at least 7 days was respected between drug administrations. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Empa: 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. Note the standard deviation is actually the coefficient of variation (CV). | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | nmol*h/L | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Primary | Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | nmol/L | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | nmol*h/L | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | ng*h/mL | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Primary | Metformin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | ng*h/mL | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Primary | Metformin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | ng/mL | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Time to Maximum Measured Concentration (Tmax) | Time from dosing to the maximum concentration of the analyte in plasma. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Median | Full Range | hours | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Terminal Elimination Rate Constant in Plasma (λz) | Terminal elimination rate constant in plasma. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | 1/h | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Terminal Half-life in Plasma (T1/2) | Terminal half-life of the analyte in plasma. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | hours | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Mean Residence Time in the Body After Oral Administration (MRTpo) | Mean residence time of the analyte in the body after oral administration. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | hours | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Apparent Clearance After Extravascular Administration (CL/F) | Apparent clearance of the analyte in the plasma after extravascular administration. Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | mL/min | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | Apparent Volume of Distribution During the Terminal Phase (Vz/F) | Apparent volume of distribution during the terminal phase (λz). Note the standard deviation is actually the CV. | Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics. | Posted | Mean | Standard Deviation | Litres | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| 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. | Treated set (TS) includes all subjects who took at least 1 dose of investigational medication and was used for safety analysis. | Posted | Number | participants | Drug administration up to 7 days after last drug administration, up to 8 days |
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Drug administration up to 7 days after last drug administration, up to 8 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 | FDC Fasted | A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions. | 0 | 15 | 2 | 15 | ||
| EG001 | Individual Tablets Fasted | 12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions. | 0 | 16 | 6 | 16 | ||
| EG002 | FDC Fed | A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions. | 0 | 14 | 8 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | 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 |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Ratio calculated as FDC fed divided by FDC fasted | ANOVA | Based on ANOVA with terms for sequence, subjects within sequence, period and treatment | Geometric mean ratio | 94.94 | Standard Deviation | 8.0 | 2-Sided | 90 | 89.85 | 100.33 | Standard deviation is actually the intra-individual gCV. | Yes | Non-Inferiority or Equivalence | No formal testing, investigation of relative bioavailability. |
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