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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000971-17 | EudraCT Number | EudraCT |
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The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Reference) | Experimental | Empagliflozin (BI 10773), Film-coated tablet, single dose |
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| B (Test 1) | Experimental | Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose |
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| C (Test 2) | Experimental | Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probenecid | Drug | Probenecid |
| |
| Rifampicin |
| Measure | Description | Time Frame |
|---|---|---|
| Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |
| Total Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total empa in plasma, per period. | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point. | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |
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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 |
|---|---|---|---|---|---|---|
| 1245.83.1 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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This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa Alone / Empa + Rifampicin / Empa + Probenecid | Patients were administered three treatments in the following order:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Rifampicin |
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| Empagliflozin | Drug | BI Drug |
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| Empagliflozin | Drug | BI Drug |
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| Rifampicin | Drug | Rifampicin |
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| Probenecid | Drug | Probenecid |
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| Empagliflozin (BI 10773) | Drug | BI Drug |
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| FG001 | Empa Alone / Empa + Probenecid / Empa + Rifampicin | Patients were administered three treatments in the following order:
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| FG002 | Empa + Rifampicin / Empa Alone / Empa + Probenecid | Patients were administered three treatments in the following order:
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| FG003 | Empa + Rifampicin / Empa + Probenecid / Empa Alone | Patients were administered three treatments in the following order:
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| FG004 | Empa + Probenecid / Empa Alone / Empa + Rifampicin | Patients were administered three treatments in the following order:
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| FG005 | Empa + Probenecid / Empa + Rifampicin / Empa Alone | Patients were administered three treatments in the following order:
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| Received Empa Alone |
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| Received Empa + Rifampicin |
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| Received Empa + Probenecid |
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| COMPLETED |
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| NOT COMPLETED |
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Treated Set. Total number of patients randomised and treated in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each. |
| 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 Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. | Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |
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| Primary | Total Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total empa in plasma, per period. | Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |
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| Secondary | Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point. | Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose |
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Treatment period until end of washout period/end of study examination, up to 29 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 | A single dose of 10mg of empagliflozin (empa). | 0 | 18 | 7 | 18 | ||
| EG001 | Empa + Rifampicin | A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin. | 0 | 18 | 9 | 18 | ||
| EG002 | Empa + Probenecid | A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3. | 0 | 16 | 6 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MEDDRA 15.0 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D011339 | Probenecid |
| D012293 | Rifampin |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| ANOVA | Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment. | Geometric Mean Ratio | 153.47 | Standard Deviation | 7.4 | 2-Sided | 90 | 146.41 | 160.88 | Standard deviation is actually the intra-subject coefficient of variation. | Yes | Non-Inferiority or Equivalence | Ratio calculated as empa plus probenecid divided by empa |
| Units | Counts |
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| Participants |
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