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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023680-18 | EudraCT Number | EudraCT |
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The objective of the study is to investigate the drug-drug interaction potential between BI 10773 and simvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment A, reference | Experimental | 1 tablet BI 10773, oral administration with 240 ml water |
|
| treatment B, reference | Experimental | 1 tablet simvastatin, oral administration with 240 ml water |
|
| treatment C, test | Experimental | 1 tablet BI 10773 + 1 tablet simvastatin, oral administration with 240 ml water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug | Medium dose oral administration |
| |
| simvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Empa: 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. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values. | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values. | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Simvastatin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | 0 hours (h), 20minutes (min), 40min, 1h, 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
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 |
|---|---|---|---|---|---|---|
| 1245.63.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
This was a randomised, open label, 3 period crossover study. Treatment periods were separated by a washout period of at least 7 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa Alone / Simvastatin Alone / Empa Plus Sim | Patients were administered three treatments in the following order:
|
| FG001 | Empa Alone / Empa Plus Sim / Simvastatin Alone | Patients were administered three treatments in the following order:
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| FG002 | Simvastatin Alone / Empa Alone / Empa Plus Sim | Patients were administered three treatments in the following order:
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| FG003 | Simvastatin Alone / Empa Plus Sim / Empa Alone | Patients were administered three treatments in the following order:
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| FG004 | Empa Plus Sim / Empa Alone / Simvastatin Alone | Patients were administered three treatments in the following order:
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| FG005 | Empa Plus Sim / Simvastatin Alone / Empa Alone | Patients were administered three treatments in the following order:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Days) |
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| Second Intervention (3 Days) |
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| Third Intervention (3 Days) |
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Treated Set: All subjects who took at least 1 dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | This was a randomised, 3-period, crossover trial. The trial was open label. The three treatments 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 | Empa: 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. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values. | Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
|
First administration of trial medication until next administration of trial medication or up to post-study visit, up to 36 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 | 25mg empagliflozin (empa) alone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal 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 |
|---|---|
| C570240 | empagliflozin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
Medium dose oral administration |
|
| simvastatin | Drug | Medium dose oral administration |
|
| BI 10773 | Drug | Medium dose oral administration |
|
| Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Empa Plus Sim |
25 mg empagliflozin (empa) together with 40 mg simvastatin (sim) |
|
|
|
| Primary | Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin. The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values. | Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
|
|
|
|
| Primary | Empa: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values | Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
|
|
|
|
| Primary | Simvastatin: Maximum Measured Concentration (Cmax) | Maximum measured concentration of the analyte in plasma, per period. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
|
|
|
|
| Secondary | Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
|
|
|
|
| Secondary | Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The geometric mean and geometric coefficient of variation (gCV) are adjusted values. | Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |
|
|
|
|
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | Simvastatin Alone | 40 mg simvastatin alone | 0 | 17 | 4 | 17 |
| EG002 | Empa Plus Sim | 25 mg empagliflozin (empa) together with 40 mg simvastatin (sim) | 0 | 18 | 5 | 18 |
| Nausea | Gastrointestinal disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
|
| Purulence | Infections and infestations | MEDDRA 14.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MEDDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.0 | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| AUC of simvastatin acid Considered characteristic is empa plus simvastatin divided by simvastatin alone. | ANOVA | Based on ANOVA with terms for sequence, subjects within sequence, period and treatment. | Geometric Mean Ratio | 104.87 | Standard Deviation | 25.5 | 2-Sided | 90 | 90.09 | 122.07 | Standard deviation is actually the gCV | Yes | Non-Inferiority or Equivalence | No formal testing, investigation of relative bioavailability |
| Cmax of simvastatin acid. Considered characteristic is empa plus simvastatin divided by simvastatin alone. | ANOVA | Based on ANOVA with terms for sequence, subjects within sequence, period and treatment. | Geometric Mean Ratio | 97.27 | Standard Deviation | 22.7 | 2-Sided | 90 | 84.90 | 111.44 | Standard deviation is actually the gCV | Yes | Non-Inferiority or Equivalence | No formal testing, investigation of relative bioavailability |
| AUC of simvastatin acid. Considered characteristic is empa plus simvastatin divided by simvastatin alone. | ANOVA | Based on ANOVA with terms for sequence, subjects within sequence, period and treatment. | Geometric Mean Ratio | 111.25 | Standard Deviation | 24.8 | 2-Sided | 90 | 95.93 | 129.02 | Standard deviation is actually the gCV | Yes | Non-Inferiority or Equivalence | No formal testing, investigation of relative bioavailability |