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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023059-27 | EudraCT Number | EudraCT |
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Relative bioavailability of BI 10773 given alone and together with verapamil
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference | Experimental | single dose BI 10773 |
|
| Test | Active Comparator | single dose BI 10773 + single dose verapamil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verapamil | Drug | single dose verapamil |
| |
| BI 10773 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Verapamil Plasma Concentration | Verapamil plasma concentration were measured in order to confirm exposure. Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ). | Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration |
Inclusion criteria:
healthy male and female subjects
Exclusion criteria:
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 |
|---|---|---|---|---|---|---|
| 1245.43.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497760 | Derived | Macha S, Sennewald R, Rose P, Schoene K, Pinnetti S, Woerle HJ, Broedl UC. Lack of clinically relevant drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and verapamil, ramipril, or digoxin in healthy volunteers. Clin Ther. 2013 Mar;35(3):226-35. doi: 10.1016/j.clinthera.2013.02.015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa / Empa Plus Verapamil | A single dose of empagliflozin (empa) 25 mg, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil. |
| FG001 | Empa Plus Verapamil / Empa | A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period of 7 Days |
| |||||||||||||
| Second Intervention |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | An open label, randomised, two-period crossover trial. The two treatments administered were
The two treatment periods were separated by a washout period of at least 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
Day1 to Day 11
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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 | A single dose of empagliflozin (empa) 25 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D014700 | Verapamil |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
single dose BI 10773 |
|
| BI 10773 | Drug | single dose BI 10773 |
|
| Time From 0 to Maximum Plasma Concentration (Tmax) | Time from last dosing to the maximum plasma concentration | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Terminal Elimination Rate Constant (λz) | Terminal elimination rate constant in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Terminal Half-life in Plasma (t1/2) | Terminal half-life of empagliflozin in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Mean Residence Time in the Body After Administration (MRTpo) | Mean residence time of empagliflozin (empa) in the body after oral administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Apparent Clearance in Plasma After Extravascular Administration (CL/F) | Apparent clearance of empagliflozin (empa) in plasma after extravascular administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Apparent Volume of Distribution Following an Extravascular Dose (Vz/F) | Apparent volume of distribution during the terminal phase following an extravascular dose. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
| Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG). | Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events. | Day1 to Day 11 |
| Assessment of Tolerability by Investigator | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable. | Within Day 15 to Day 25 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil. |
|
|
|
| Primary | Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
|
| Secondary | Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
|
| Secondary | Time From 0 to Maximum Plasma Concentration (Tmax) | Time from last dosing to the maximum plasma concentration | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Median | Full Range | h | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Terminal Elimination Rate Constant (λz) | Terminal elimination rate constant in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Terminal Half-life in Plasma (t1/2) | Terminal half-life of empagliflozin in plasma. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Mean Residence Time in the Body After Administration (MRTpo) | Mean residence time of empagliflozin (empa) in the body after oral administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Apparent Clearance in Plasma After Extravascular Administration (CL/F) | Apparent clearance of empagliflozin (empa) in plasma after extravascular administration. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Apparent Volume of Distribution Following an Extravascular Dose (Vz/F) | Apparent volume of distribution during the terminal phase following an extravascular dose. Note: The numbers provide below for standard deviation are of Coefficient of Variation. | Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Other Pre-specified | Verapamil Plasma Concentration | Verapamil plasma concentration were measured in order to confirm exposure. Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ). | Treated set (TS) included all subjects who had taken at least one dose of trial medication. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration |
|
|
|
| Secondary | Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG). | Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events. | Treated set (TS) included all subjects who had taken at least one dose of trial medication. | Posted | Number | participants | Day1 to Day 11 |
|
|
|
| Secondary | Assessment of Tolerability by Investigator | Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable. | Treated set | Posted | Number | percentage of participants | Within Day 15 to Day 25 |
|
|
|
| 0 |
| 16 |
| 8 |
| 16 |
| EG001 | Empa Plus Verapamil | A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil. | 0 | 16 | 9 | 16 |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Induration | General disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 13.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Not Satisfactory |
|
| Bad |
|
| Not assessable |
|