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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022469-81 | EudraCT Number | EudraCT |
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The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 Final Formulation | Experimental | one single film-coated tablet in the morning |
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| BI 10773 XX Trial Formulation 2 | Experimental | one single dose tablet in the morning |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 XX (Trial Formulation 2) | Drug | one single dose tablet in the morning |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 (%)). | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV (%). | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%). | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (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:
Healthy male and female subjects
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.51.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa FF / Empa TF2 | Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments. |
| FG001 | Empa TF2 / Empa FF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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| BI 10773 (Final Formulation) | Drug | one single film-coated tablet in the morning |
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Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments. |
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| NOT COMPLETED |
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| Washout Period of 7 Days |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | An open-label, randomised, two-way crossover study. The two treatments administered were
Between drug administrations 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Mean | Standard Deviation | nmol*h/L | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Primary | 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 subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Mean | Standard Deviation | nmol/L | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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| Secondary | 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 subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Mean | Standard Deviation | nmol*h/L | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
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From drug administration until end of study visit, up to 10 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 FF | Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours. | 0 | 22 | 1 | 22 | ||
| EG001 | Empa TF2 | Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours. | 1 | 23 | 4 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine with aura | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 13.1 | 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 |
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