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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023170-40 | EudraCT Number | EudraCT |
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The objective of the study is to investigate the relative bioavailability of digoxin after concomitant multiple oral administration of BI 10773 and a single dose of digoxin in comparison to digoxin given alone to healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin alone (Reference) | Experimental | Tablet, oral administration with 240 mL water |
|
| Digoxin plus BI 10773 (Test) | Experimental | Tablets, oral administration with 240 mL water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin plus BI 10773 | Drug | Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity. | 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose |
| Digoxin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of digoxin, per period. | 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point. | 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose |
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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 |
|---|---|---|---|---|---|---|
| 1245.40.1 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 | Study Total | This was a randomised, two-period cross-over trial, the two treatments administered were
Between treatment periods there was a washout period of at least 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period of at Least 14 Days |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Total | This was a randomised, two-period, cross-over trial, the two treatments administered were
Between treatment periods there was a washout period of at least 14 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 | Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity. | Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng-h/mL | 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose |
|
First administration of trial medication until 7 days after last administration of trial medication for Digoxin and BI 10773 + Digoxin, 30 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 | Digoxin Alone | A single dose of digoxin 0.5 mg on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General 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 |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Digoxin 0.5 mg as single dose |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Digoxin and Empa |
Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5. |
|
|
| Primary | Digoxin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of digoxin, per period. | Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose |
|
|
|
| Secondary | Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point. | Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Digoxin and Empa | Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5. | 0 | 20 | 0 | 20 |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |