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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002836-13 | EudraCT Number | EudraCT |
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Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | high dose of empagliflozin after overnight fasting for at least 10 h |
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| Treatment B | Experimental | high dose of empagliflozin after a standardised high fat breakfast |
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| Treatment C | Experimental | low dose empagliflozin after overnight fasting for at least 10 h |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | high dose of empagliflozin after overnight fasting for at least 10 h |
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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 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities. | 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities. | 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator. | Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section. |
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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 |
|---|---|---|---|---|---|---|
| 1245.79.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted | Patients were administered three treatments in the following order:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Empagliflozin |
| Drug |
low dose empagliflozin after overnight fasting for at least 10 h |
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| Empagliflozin | Drug | high dose of empagliflozin after a standardised high fat breakfast |
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| Screening until end of trial, average of 45 days |
| FG001 | Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed | Patients were administered three treatments in the following order:
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| FG002 | Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted | Patients were administered three treatments in the following order:
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| FG003 | Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted | Patients were administered three treatments in the following order:
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| FG004 | Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed | Patients were administered three treatments in the following order:
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| FG005 | Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted | Patients were administered three treatments in the following order:
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Overall | Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments. |
| 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 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities. | All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Primary | Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities. | All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration |
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| Secondary | Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator. | Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section. | Treated Set(TS): TS includes all subjects who have taken at least 1 dose of trial medication | Posted | Number | participants | Screening until end of trial, average of 45 days |
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Drug administration until beginning of next sequence/end of trial, average of 24 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 25 mg Fasted | A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours. | 0 | 18 | 2 | 18 | ||
| EG001 | Empa 25 mg Fed | A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast. | 0 | 18 | 2 | 18 | ||
| EG002 | Empa 10 mg Fasted | A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours. | 0 | 18 | 4 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MEDDRA 15.0 | Systematic Assessment |
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| Abdominal pain | 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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| Rhinitis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
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| Myosclerosis | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
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| Migraine | 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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| Neurodermatitis | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | 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 |
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| ANCOVA | ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables. | Does proportionality would be assumed if the 95% confidence interval includes one. | Slope | 0.9367 | Standard Error of the Mean | 0.0178 | 2-Sided | 95 | 0.8988 | 0.9746 | Yes | Non-Inferiority or Equivalence | This is an analysis of dose proportionality |
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