Trial Outcomes & Findings for Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets (NCT NCT01975220)
NCT ID: NCT01975220
Last Updated: 2017-03-08
Results Overview
Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Results posted on
2017-03-08
Participant Flow
Participant milestones
| Measure |
High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets
1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet
3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet
|
High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets
1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet
3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet
|
Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets
2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets
|
Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets
4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;
12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets
|
|---|---|---|---|---|---|---|
|
Test Period 1
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Test Period 1
COMPLETED
|
12
|
11
|
12
|
12
|
12
|
12
|
|
Test Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Test Period 2
STARTED
|
12
|
11
|
12
|
12
|
12
|
12
|
|
Test Period 2
COMPLETED
|
12
|
11
|
12
|
12
|
12
|
12
|
|
Test Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets
1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet
3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet
|
High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets
1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet
3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet
|
Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets
2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets
|
Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets
4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;
12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets
|
|---|---|---|---|---|---|---|
|
Test Period 1
Not treated
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
Baseline characteristics by cohort
| Measure |
High Dose, Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
High Dose, Fed
n=24 Participants
1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
Low Dose, Fasted
n=24 Participants
2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Gender
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic set (PKS): This set includes all subjects of the Treated set (TS) who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints.
Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin
Outcome measures
| Measure |
High Dose, Fed: 3 Single Tablets
n=24 Participants
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
Low Dose, Fasted: 2 FDC Tablets
n=24 Participants
2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
|
Low Dose, Fasted: 4 Single Tablets
n=24 Participants
4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
|
High Dose, Fasted: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
|
High Dose, Fasted: 3 Single Tablets
n=23 Participants
3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
High Dose, Fed: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin
|
5850 nmol*h/L
Geometric Coefficient of Variation 19.6
|
7160 nmol*h/L
Geometric Coefficient of Variation 19.5
|
7110 nmol*h/L
Geometric Coefficient of Variation 20.5
|
6430 nmol*h/L
Geometric Coefficient of Variation 22.3
|
6430 nmol*h/L
Geometric Coefficient of Variation 21.7
|
5690 nmol*h/L
Geometric Coefficient of Variation 21.0
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin
Outcome measures
| Measure |
High Dose, Fed: 3 Single Tablets
n=24 Participants
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
Low Dose, Fasted: 2 FDC Tablets
n=24 Participants
2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
|
Low Dose, Fasted: 4 Single Tablets
n=24 Participants
4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
|
High Dose, Fasted: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
|
High Dose, Fasted: 3 Single Tablets
n=23 Participants
3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
High Dose, Fed: 1 FDC Tablet
n=24 Participants
1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
|
|---|---|---|---|---|---|---|
|
AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin
|
13100 ng*h/mL
Geometric Coefficient of Variation 21.1
|
10200 ng*h/mL
Geometric Coefficient of Variation 38.5
|
10300 ng*h/mL
Geometric Coefficient of Variation 38.3
|
6350 ng*h/mL
Geometric Coefficient of Variation 32.8
|
6700 ng*h/mL
Geometric Coefficient of Variation 28.9
|
13000 ng*h/mL
Geometric Coefficient of Variation 23.6
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin
Outcome measures
| Measure |
High Dose, Fed: 3 Single Tablets
n=24 Participants
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
Low Dose, Fasted: 2 FDC Tablets
n=24 Participants
2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
|
Low Dose, Fasted: 4 Single Tablets
n=24 Participants
4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
|
High Dose, Fasted: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
|
High Dose, Fasted: 3 Single Tablets
n=23 Participants
3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
High Dose, Fed: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
|
|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin
|
601 nmol/L
Geometric Coefficient of Variation 25.0
|
1010 nmol/L
Geometric Coefficient of Variation 27.0
|
963 nmol/L
Geometric Coefficient of Variation 29.7
|
886 nmol/L
Geometric Coefficient of Variation 27.3
|
810 nmol/L
Geometric Coefficient of Variation 28.1
|
559 nmol/L
Geometric Coefficient of Variation 29.0
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Cmax (maximum measured concentration of the analyte in plasma); Metformin
Outcome measures
| Measure |
High Dose, Fed: 3 Single Tablets
n=24 Participants
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
Low Dose, Fasted: 2 FDC Tablets
n=24 Participants
2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
|
Low Dose, Fasted: 4 Single Tablets
n=24 Participants
4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
|
High Dose, Fasted: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
|
High Dose, Fasted: 3 Single Tablets
n=23 Participants
3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
High Dose, Fed: 1 FDC Tablet
n=24 Participants
1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
|
|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin
|
1070 ng/mL
Geometric Coefficient of Variation 22.8
|
1300 ng/mL
Geometric Coefficient of Variation 34.4
|
1330 ng/mL
Geometric Coefficient of Variation 41.3
|
822 ng/mL
Geometric Coefficient of Variation 37.4
|
851 ng/mL
Geometric Coefficient of Variation 28.8
|
1180 ng/mL
Geometric Coefficient of Variation 27.4
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin
Outcome measures
| Measure |
High Dose, Fed: 3 Single Tablets
n=24 Participants
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
Low Dose, Fasted: 2 FDC Tablets
n=24 Participants
2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
|
Low Dose, Fasted: 4 Single Tablets
n=24 Participants
4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
|
High Dose, Fasted: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
|
High Dose, Fasted: 3 Single Tablets
n=23 Participants
3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
High Dose, Fed: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
|
|---|---|---|---|---|---|---|
|
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin
|
5970 nmol*h/L
Geometric Coefficient of Variation 20.5
|
7240 nmol*h/L
Geometric Coefficient of Variation 19.7
|
7180 nmol*h/L
Geometric Coefficient of Variation 20.8
|
6510 nmol*h/L
Geometric Coefficient of Variation 22.9
|
6490 nmol*h/L
Geometric Coefficient of Variation 21.6
|
5800 nmol*h/L
Geometric Coefficient of Variation 21.8
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin
Outcome measures
| Measure |
High Dose, Fed: 3 Single Tablets
n=24 Participants
3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
Low Dose, Fasted: 2 FDC Tablets
n=24 Participants
2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
|
Low Dose, Fasted: 4 Single Tablets
n=24 Participants
4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
|
High Dose, Fasted: 1 FDC Tablet
n=23 Participants
1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
|
High Dose, Fasted: 3 Single Tablets
n=23 Participants
3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
|
High Dose, Fed: 1 FDC Tablet
n=24 Participants
1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
|
|---|---|---|---|---|---|---|
|
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin
|
13200 ng*h/mL
Geometric Coefficient of Variation 21.6
|
10500 ng*h/mL
Geometric Coefficient of Variation 41.9
|
10400 ng*h/mL
Geometric Coefficient of Variation 39.9
|
6490 ng*h/mL
Geometric Coefficient of Variation 35.2
|
6790 ng*h/mL
Geometric Coefficient of Variation 29.6
|
13200 ng*h/mL
Geometric Coefficient of Variation 24.0
|
Adverse Events
High Dose, Fasted: 1 FDC Tablet
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose, Fasted: 3 Single Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Dose, Fed: 1 FDC Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Dose, Fed: 3 Single Tablets
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Low Dose, Fasted: 2 FDC Tablets
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low Dose, Fasted: 4 Single Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose, Fasted: 1 FDC Tablet
n=23 participants at risk
1 fixed dose combination (FDC) tablet under fasted conditions:
25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet
|
High Dose, Fasted: 3 Single Tablets
n=23 participants at risk
3 single tablets under fasted conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
High Dose, Fed: 1 FDC Tablet
n=24 participants at risk
1 fixed dose combination (FDC) tablet under fed conditions:
25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet
|
High Dose, Fed: 3 Single Tablets
n=24 participants at risk
3 single tablets under fed conditions:
1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets
|
Low Dose, Fasted: 2 FDC Tablets
n=24 participants at risk
2 fixed dose combination (FDC) tablets under fasted conditions:
12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets
|
Low Dose, Fasted: 4 Single Tablets
n=24 participants at risk
4 single tablets under fed conditions:
1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
13.0%
3/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
4.2%
1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
8.3%
2/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
12.5%
3/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
4.3%
1/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
4.2%
1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
8.3%
2/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
0.00%
0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
4.2%
1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER