CompletedNCT01211197Updated Aug 21, 2015Results posted

Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

A Phase 1 interventional study of C: BI 10773 / metformin tablet and B: BI 10773 tablet and metformin tablet in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-21.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

Conditions studied

Diabetes Mellitus, Type 2

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Diabetes Mellitus, Type 2 9,359

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 16 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy males and females according to the following criteria
Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria

Exclusion criteria:

Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
A
3 treatments will be investigated in randomized order
Drug: A: BI 10773 / metformin tablet
Experimental
B
3 treatments will be investigated in randomized order
Drug: B: BI 10773 tablet and metformin tablet
Experimental
C
3 treatments will be investigated in randomized order
Drug: C: BI 10773 / metformin tablet

Interventions

DrugC: BI 10773 / metformin tablet
BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal
DrugB: BI 10773 tablet and metformin tablet
BI 10773 and metformin single tablets, administered together in fasted state
DrugA: BI 10773 / metformin tablet
BI 10773 / metformin fixed dose combination tablet in fasted state

What researchers measure

Primary outcomes

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. Note the standard deviation is actually the coefficient of variation (CV).
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 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 empagliflozin (empa) in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Maximum Measured Concentration (Cmax)
Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration

Secondary outcomes

Empa: 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: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of metformin 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: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time from dosing to the maximum concentration of the analyte in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Elimination Rate Constant in Plasma (λz)
Terminal elimination rate constant in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Terminal Half-life in Plasma (T1/2)
Terminal half-life of the analyte in plasma. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Mean Residence Time in the Body After Oral Administration (MRTpo)
Mean residence time of the analyte in the body after oral administration. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Clearance After Extravascular Administration (CL/F)
Apparent clearance of the analyte in the plasma after extravascular administration. Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Apparent volume of distribution during the terminal phase (λz). Note the standard deviation is actually the CV.
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Time frame: Drug administration up to 7 days after last drug administration, up to 8 days

Results

Posted Aug 21, 2015

Participant flow

Treatment Period 1 (1 Day)

Participant flow — Treatment Period 1 (1 Day)
Milestone	FDC Fasted / Individual Tablets Fasted / FDC Fed	FDC Fasted / FDC Fed / Individual Tablets Fasted	Individual Tablets Fasted / FDC Fasted / FDC Fed	Individual Tablets Fasted / FDC Fed / FDC Fasted	FDC Fed / FDC Fasted / Individual Tablets Fasted	FDC Fed / Individual Tablets Fasted / FDC Fasted
Started	3	3	3	3	2	2
Completed	3	3	3	3	2	2
Not completed	0	0	0	0	0	0

Washout Period 1 (7 Days)

Participant flow — Washout Period 1 (7 Days)
Milestone	FDC Fasted / Individual Tablets Fasted / FDC Fed	FDC Fasted / FDC Fed / Individual Tablets Fasted	Individual Tablets Fasted / FDC Fasted / FDC Fed	Individual Tablets Fasted / FDC Fed / FDC Fasted	FDC Fed / FDC Fasted / Individual Tablets Fasted	FDC Fed / Individual Tablets Fasted / FDC Fasted
Started	3	3	3	3	2	2
Completed	3	3	2	3	2	2
Not completed	0	0	1	0	0	0
Withdrew: Withdrawal by subject	0	0	1	0	0	0

Treatment Period 2 (1 Day)

Participant flow — Treatment Period 2 (1 Day)
Milestone	FDC Fasted / Individual Tablets Fasted / FDC Fed	FDC Fasted / FDC Fed / Individual Tablets Fasted	Individual Tablets Fasted / FDC Fasted / FDC Fed	Individual Tablets Fasted / FDC Fed / FDC Fasted	FDC Fed / FDC Fasted / Individual Tablets Fasted	FDC Fed / Individual Tablets Fasted / FDC Fasted
Started	3	3	2	3	2	2
Completed	3	3	2	3	2	2
Not completed	0	0	0	0	0	0

Washout Period 2 (7 Days)

Participant flow — Washout Period 2 (7 Days)
Milestone	FDC Fasted / Individual Tablets Fasted / FDC Fed	FDC Fasted / FDC Fed / Individual Tablets Fasted	Individual Tablets Fasted / FDC Fasted / FDC Fed	Individual Tablets Fasted / FDC Fed / FDC Fasted	FDC Fed / FDC Fasted / Individual Tablets Fasted	FDC Fed / Individual Tablets Fasted / FDC Fasted
Started	3	3	2	3	2	2
Completed	2	3	2	3	2	2
Not completed	1	0	0	0	0	0
Withdrew: Adverse event	1	0	0	0	0	0

Treatment Period 3 (1 Day)

Participant flow — Treatment Period 3 (1 Day)
Milestone	FDC Fasted / Individual Tablets Fasted / FDC Fed	FDC Fasted / FDC Fed / Individual Tablets Fasted	Individual Tablets Fasted / FDC Fasted / FDC Fed	Individual Tablets Fasted / FDC Fed / FDC Fasted	FDC Fed / FDC Fasted / Individual Tablets Fasted	FDC Fed / Individual Tablets Fasted / FDC Fasted
Started	2	3	2	3	2	2
Completed	2	3	2	3	2	2
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryEmpa: 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:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · nmol*h/L

Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
nmol*h/L	FDC Fasted	Individual Tablets Fasted	FDC Fed
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	2920 ± 16.2	2860 ± 18.5	2710 ± 15.0

Statistical analysis

FDC Fasted vs Individual Tablets Fasted · ANOVA · Geometric mean ratio: 100.59 · 90% CI 95.75 to 105.67Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).
FDC Fasted vs FDC Fed · ANOVA · Geometric mean ratio: 94.94 · 90% CI 89.85 to 100.33Standard deviation is actually the intra-individual gCV.

PrimaryEmpa: Maximum Measured Concentration (Cmax)

Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · nmol/L

Empa: Maximum Measured Concentration (Cmax)
nmol/L	FDC Fasted	Individual Tablets Fasted	FDC Fed
Empa: Maximum Measured Concentration (Cmax)	404 ± 17.4	405 ± 15.8	259 ± 20.3

Statistical analysis

FDC Fasted vs Individual Tablets Fasted · ANOVA · Geometric mean ratio: 99.31 · 90% CI 91.76 to 107.49Standard deviation is actually the intra-individual gCV.
FDC Fasted vs FDC Fed · ANOVA · Geometric mean ratio: 64.30 · 90% CI 55.97 to 73.87Standard deviation is actually the intra-individual gCV.

SecondaryEmpa: 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:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · nmol*h/L

Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
nmol*h/L	FDC Fasted	Individual Tablets Fasted	FDC Fed
Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	2860 ± 16.3	2800 ± 18.6	2640 ± 15.1

Statistical analysis

FDC Fasted vs Individual Tablets Fasted · ANOVA · Geometric mean ratio: 100.94 · 90% CI 96.03 to 106.11Standard deviation is actually the intra-individual gCV.
FDC Fasted vs FDC Fed · ANOVA · Geometric mean ratio: 94.39 · 90% CI 89.22 to 99.87Standard deviation is actually the intra-individual gCV.

SecondaryMetformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)

Area under the concentration-time curve of metformin 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:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · ng*h/mL

Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
ng*h/mL	FDC Fasted	Individual Tablets Fasted	FDC Fed
Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	9900 ± 17.9	9720 ± 22.3	9550 ± 19.7

Statistical analysis

FDC Fasted vs Individual Tablets Fasted · ANOVA · Geometric mean ratio: 103.13 · 90% CI 95.59 to 111.25Standard deviation is actually the intra-individual gCV.
FDC Fasted vs FDC Fed · ANOVA · Geometric mean ratio: 96.96 · 90% CI 87.23 to 107.78Standard deviation is actually the intra-individual gCV.

PrimaryMetformin: Area Under the Curve 0 to Infinity (AUC0-∞)

Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · ng*h/mL

Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
ng*h/mL	FDC Fasted	Individual Tablets Fasted	FDC Fed
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)	10300 ± 16.9	10100 ± 21.2	10200 ± 15.6

Statistical analysis

FDC Fasted vs Individual Tablets Fasted · ANOVA · Geometric mean ratio: 102.15 · 90% CI 93.87 to 111.15Standard deviation is actually the intra-individual gCV.
FDC Fasted vs FDC Fed · ANOVA · Geometric mean ratio: 100.67 · 90% CI 91.70 to 110.51Standard deviation is actually the intra-individual gCV.

PrimaryMetformin: Maximum Measured Concentration (Cmax)

Maximum measured concentration of metformin in plasma. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · ng/mL

Metformin: Maximum Measured Concentration (Cmax)
ng/mL	FDC Fasted	Individual Tablets Fasted	FDC Fed
Metformin: Maximum Measured Concentration (Cmax)	1550 ± 19.1	1530 ± 23.4	1180 ± 25.5

Statistical analysis

FDC Fasted vs Individual Tablets Fasted · ANOVA · Geometric mean ratio: 103.49 · 90% CI 95.30 to 112.39Standard deviation is actually the intra-individual gCV.
FDC Fasted vs FDC Fed · ANOVA · Geometric mean ratio: 75.13 · 90% CI 63.68 to 88.64Standard deviation is actually the intra-individual gCV.

SecondaryTime to Maximum Measured Concentration (Tmax)

Time from dosing to the maximum concentration of the analyte in plasma. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Median · hours

Time to Maximum Measured Concentration (Tmax)
hours	FDC Fasted	Individual Tablets Fasted	FDC Fed
Tmax of empagliflozin	1.50 ± 34.2	1.75 ± 27.1	3.00 ± 54.6
Tmax of metformin	2.50 ± 20.9	2.50 ± 26.3	3.00 ± 49.8

SecondaryTerminal Elimination Rate Constant in Plasma (λz)

Terminal elimination rate constant in plasma. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · 1/h

Terminal Elimination Rate Constant in Plasma (λz)
1/h	FDC Fasted	Individual Tablets Fasted	FDC Fed
λz of empagliflozin	0.0559 ± 43.9	0.0601 ± 53.2	0.0498 ± 46.6
λz of metformin	0.0822 ± 73.3	0.0756 ± 82.7	0.0590 ± 108

SecondaryTerminal Half-life in Plasma (T1/2)

Terminal half-life of the analyte in plasma. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · hours

Terminal Half-life in Plasma (T1/2)
hours	FDC Fasted	Individual Tablets Fasted	FDC Fed
T1/2 of empagliflozin	15.1 ± 46.6	16.0 ± 61.3	16.7 ± 43.0
T1/2 of metformin	16.6 ± 94.6	17.8 ± 76.9	30.5 ± 89.0

SecondaryMean Residence Time in the Body After Oral Administration (MRTpo)

Mean residence time of the analyte in the body after oral administration. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · hours

Mean Residence Time in the Body After Oral Administration (MRTpo)
hours	FDC Fasted	Individual Tablets Fasted	FDC Fed
MRTpo of empagliflozin	10.5 ± 17.6	10.9 ± 25.1	13.9 ± 23.0
MRTpo of metformin	9.53 ± 52.0	10.2 ± 52.1	19.4 ± 101

SecondaryApparent Clearance After Extravascular Administration (CL/F)

Apparent clearance of the analyte in the plasma after extravascular administration. Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · mL/min

Apparent Clearance After Extravascular Administration (CL/F)
mL/min	FDC Fasted	Individual Tablets Fasted	FDC Fed
CL/F of empagliflozin	162 ± 15.0	166 ± 17.1	174 ± 13.3
CL/F of metformin	1670 ± 20.2	1730 ± 25.4	1670 ± 18.8

SecondaryApparent Volume of Distribution During the Terminal Phase (Vz/F)

Apparent volume of distribution during the terminal phase (λz). Note the standard deviation is actually the CV.

Time frame:: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Reported as:: Mean · Litres

Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Litres	FDC Fasted	Individual Tablets Fasted	FDC Fed
Vz/F of empagliflozin	210 ± 45.3	222 ± 58.0	250 ± 44.3
Vz/F of metformin	2410 ± 99.5	2650 ± 86.0	4670 ± 112

SecondaryClinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.

Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Time frame:: Drug administration up to 7 days after last drug administration, up to 8 days
Reported as:: Number · participants

Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.
participants	FDC Fasted	Individual Tablets Fasted	FDC Fed
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.	0	0	0

Adverse events

Collected over Drug administration up to 7 days after last drug administration, up to 8 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FDC Fasted	—	0/15 (0%)	2/15 (13.3%)
Individual Tablets Fasted	—	0/16 (0%)	6/16 (37.5%)
FDC Fed	—	0/14 (0%)	8/14 (57.1%)

Most frequent other events

Most frequent other events
Event	FDC Fasted	Individual Tablets Fasted	FDC Fed
DiarrhoeaGastrointestinal disorders	2/15	3/16	3/14
NasopharyngitisInfections and infestations	0/15	0/16	1/14
RhinitisInfections and infestations	0/15	0/16	1/14
Ligament sprainInjury, poisoning and procedural complications	0/15	0/16	1/14
DizzinessNervous system disorders	0/15	1/16	1/14
HeadacheNervous system disorders	1/15	1/16	1/14
Dermatitis contactSkin and subcutaneous tissue disorders	0/15	0/16	1/14
Urinary tract infectionInfections and infestations	0/15	1/16	0/14
WoundInjury, poisoning and procedural complications	0/15	1/16	0/14
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/15	1/16	0/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Study Overall
Mean	35.8 ± 7.7

Sex: Female, Male
Sex: Female, Male(Participants)	Study Overall
Female	9
Male	7

Study locations

1 site

1276.5.1 Boehringer Ingelheim Investigational Site
Biberach, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01211197
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Sep 29, 2010
Start date: Oct 2010
Primary completion: Dec 2010
Results posted: Aug 21, 2015
Last update: Aug 21, 2015

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

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Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability

Study summary

Conditions studied

Browse trials for

In context

Diabetes Mellitus, Type 2

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria