Healthy
Conditions
Brief summary
To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.
Interventions
DRUGBI 10773
1 tablet single dose BI 10773 in the morning
DRUGGemfibrozil
Gemfibrozil 600 mg bid for 5 days
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy male and female subjects
Exclusion criteria
\- Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) | 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose | Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV). |
| Total Empa: Maximum Measured Concentration (Cmax) | 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose | Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose | Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point. The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population The two treatments given in a randomised order were:
* Empagliflozin 25mg (Empa) was given as a single dose on Day 1
* Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
Between treatments there was a washout period of at least 7 days. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 18 | 3 / 18 | 6 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
Time frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Population: PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Empa Alone | Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) | 4708.33 nmol*h/L | Geometric Coefficient of Variation 7.5 |
| Empa and Gemfibrozil | Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞) | 7462.74 nmol*h/L | Geometric Coefficient of Variation 7.5 |
90% CI: [151.77, 165.53]ANOVA
Primary
Total Empa: Maximum Measured Concentration (Cmax)
Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period. The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
Time frame: 0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Population: PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Empa Alone | Total Empa: Maximum Measured Concentration (Cmax) | 602.24 nmol/L | Geometric Coefficient of Variation 13.8 |
| Empa and Gemfibrozil | Total Empa: Maximum Measured Concentration (Cmax) | 692.59 nmol/L | Geometric Coefficient of Variation 13.8 |
90% CI: [106.15, 124.59]ANOVA
Secondary
Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point. The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).
Time frame: 0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose
Population: PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Empa Alone | Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | 4643.81 nmol*h/L | Geometric Coefficient of Variation 7.7 |
| Empa and Gemfibrozil | Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz) | 7350.84 nmol*h/L | Geometric Coefficient of Variation 7.7 |
90% CI: [151.41, 165.49]ANOVA