Healthy
Conditions
Brief summary
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).
Interventions
DRUGBI 10773 XX (Trial Formulation 2)
one single dose tablet in the morning
DRUGBI 10773 (Final Formulation)
one single film-coated tablet in the morning
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve 0 to Infinity (AUC0-∞) | 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 | 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 (%)). |
| Maximum Measured Concentration (Cmax) | 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 of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | 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 | 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 (%). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Overall An open-label, randomised, two-way crossover study. The two treatments administered were
* A single dose of empagliflozin (empa) 25mg, final formulation
* A single dose of empa 25mg, trial formulation 2
Between drug administrations there was a washout period of at least 7 days. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period of 7 Days | Adverse Event | 0 | 2 |
| Washout Period of 7 Days | Non-compliant with protocol | 1 | 0 |
Baseline characteristics
| Characteristic | Study Overall |
|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 22 | 4 / 23 |
| serious Total, serious adverse events | 0 / 22 | 1 / 23 |
Outcome results
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 (%)).
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empa FF | Area Under the Curve 0 to Infinity (AUC0-∞) | 5200 nmol*h/L | Standard Deviation 20.7 |
| Empa TF2 | Area Under the Curve 0 to Infinity (AUC0-∞) | 5090 nmol*h/L | Standard Deviation 17.7 |
Comparison: Ratio calculated as empa final formulation divided by empa trial formulation 290% CI: [98.1, 105.37]ANOVA
Primary
Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV (%).
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empa FF | Maximum Measured Concentration (Cmax) | 764 nmol/L | Standard Deviation 26.5 |
| Empa TF2 | Maximum Measured Concentration (Cmax) | 764 nmol/L | Standard Deviation 23 |
Comparison: Ratio calculated as empa final formulation divided by empa trial formulation 290% CI: [90.18, 109.68]ANOVA
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 (%).
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Empa FF | Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | 5140 nmol*h/L | Standard Deviation 20.8 |
| Empa TF2 | Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | 5030 nmol*h/L | Standard Deviation 18 |
Comparison: Ratio calculated as empa final formulation divided by empa trial formulation 290% CI: [98.26, 105.48]ANOVA