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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023152-85 | EudraCT Number | EudraCT |
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To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 | Active Comparator | Subject to receive one single dose BI 10773 |
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| BI 10773 plus gemfibrozil | Experimental | Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug | 1 tablet single dose BI 10773 in the morning |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV). | 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose |
| Total Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV). | 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point. The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV). | 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose |
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Inclusion criteria:
- Healthy male and female subjects
Exclusion criteria:
- Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.58.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24491572 | Derived | Macha S, Koenen R, Sennewald R, Schone K, Hummel N, Riedmaier S, Woerle HJ, Salsali A, Broedl UC. Effect of gemfibrozil, rifampicin, or probenecid on the pharmacokinetics of the SGLT2 inhibitor empagliflozin in healthy volunteers. Clin Ther. 2014 Feb 1;36(2):280-90.e1. doi: 10.1016/j.clinthera.2014.01.003. Epub 2014 Feb 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa First, Then Empa and Gemfibrozil | Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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| Gemfibrozil |
| Drug |
Gemfibrozil 600 mg bid for 5 days |
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| BI 10773 | Drug | 1 tablet single dose BI 10773 in the morning |
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| Empa and Gemfibrozil First, Then Empa |
Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period of at Least 7 Days |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | The two treatments given in a randomised order were:
Between treatments there was a washout period of at least 7 days. |
| Units | Counts |
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| 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 | Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV). | PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose |
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| Primary | Total Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV). | PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose |
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| Secondary | Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point. The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV). | PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose |
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First administration of trial medication until next administration of trial medication or up to post-study visit, 20 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 Alone | Empagliflozin (Empa) 25mg given as a single dose on Day 1. | 0 | 18 | 8 | 18 | ||
| EG001 | Empa and Gemfibrozil | Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. | 0 | 18 | 3 | 18 | ||
| EG002 | Gemfibrozil Alone | Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period. | 0 | 18 | 6 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
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| Muscle disorder | Musculoskeletal and connective tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MEDDRA 14.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MEDDRA 14.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 14.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MEDDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D015248 | Gemfibrozil |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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