Trial Outcomes & Findings for Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets (NCT NCT02821910)
NCT ID: NCT02821910
Last Updated: 2020-03-05
Results Overview
Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented. Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example * The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subject's experiencing emesis) * A pre-dose concentration was \>5% of the Cmax value measured in that subject * Missing samples or concentration data at important phases of PK disposition curve
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration
Results posted on
2020-03-05
Participant Flow
The subjects were randomly allocated to the 2 treatment sequences (test (T) - reference (R) or R-T) in 3 separate trial parts. There was a wash-out period of at least 35 days between the treatments.Treatments were administered as single doses in the fed state in Parts 1 and 3, and in the fasted state in Part 2.
Participant milestones
| Measure |
FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1)
Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1)
Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2)
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2)
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3)
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3)
Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
10
|
10
|
7
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
10
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1)
Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1)
Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2)
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2)
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3)
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3)
Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Other than specified
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
Baseline characteristics by cohort
| Measure |
FDC 25 Fed (T1)/ E25+L5+M1000 Fed (R1) (Part 1)
n=7 Participants
Subjects were orally administered single dose of 25 milligram (mg) empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 millilitre (mL) of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)/ FDC 25 Fed (T1) (Part 1)
n=8 Participants
Subjects were orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)/ E25+L5+M1000 Fast (R2) (Part 2)
n=10 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)/ FDC 25 Fast (T2) (Part 2)
n=10 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after an overnight fast of at least 10 h followed by a wash-out period of at least 35 days and then orally administered 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)/ E10+L5+M1000 Fed (R3) (Part 3)
n=7 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)/ FDC 10 Fed (T3) (Part 3)
n=8 Participants
Subjects were orally administered free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast followed by a wash-out period of at least 35 days and then orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
37.3 years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
35.3 years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
36.0 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects in the TS who provided at least 1 primary or secondary PK parameter that was not excluded according to the criterion's for non-evaluable above.
Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented. Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example * The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subject's experiencing emesis) * A pre-dose concentration was \>5% of the Cmax value measured in that subject * Missing samples or concentration data at important phases of PK disposition curve
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
|
5990 nanomoles (nmol)*hours (h)/litres (L)
Geometric Coefficient of Variation 25.6
|
6120 nanomoles (nmol)*hours (h)/litres (L)
Geometric Coefficient of Variation 22.8
|
6430 nanomoles (nmol)*hours (h)/litres (L)
Geometric Coefficient of Variation 20.2
|
6250 nanomoles (nmol)*hours (h)/litres (L)
Geometric Coefficient of Variation 18.7
|
2080 nanomoles (nmol)*hours (h)/litres (L)
Geometric Coefficient of Variation 15.4
|
2130 nanomoles (nmol)*hours (h)/litres (L)
Geometric Coefficient of Variation 15.5
|
PRIMARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
|
13900 nanograms (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 29.6
|
13900 nanograms (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 30.9
|
7920 nanograms (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 31.3
|
8260 nanograms (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 33.4
|
12000 nanograms (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 26.0
|
12200 nanograms (ng)*h/ milliliter (mL)
Geometric Coefficient of Variation 25.9
|
PRIMARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Maximum measured concentration of Empagliflozin in plasma (Cmax) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Empagliflozin in Plasma (Cmax)
|
594 nmol/L
Geometric Coefficient of Variation 17.7
|
630 nmol/L
Geometric Coefficient of Variation 20.4
|
872 nmol/L
Geometric Coefficient of Variation 24.5
|
817 nmol/L
Geometric Coefficient of Variation 31.5
|
232 nmol/L
Geometric Coefficient of Variation 20.5
|
235 nmol/L
Geometric Coefficient of Variation 18.8
|
PRIMARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Maximum measured concentration of Metformin in plasma (Cmax) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Metformin in Plasma (Cmax)
|
1290 ng/mL
Geometric Coefficient of Variation 25.0
|
1300 ng/mL
Geometric Coefficient of Variation 21.4
|
1010 ng/mL
Geometric Coefficient of Variation 31.1
|
1020 ng/mL
Geometric Coefficient of Variation 32.8
|
1170 ng/mL
Geometric Coefficient of Variation 33.3
|
1150 ng/mL
Geometric Coefficient of Variation 32.6
|
PRIMARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Maximum measured concentration of Linagliptin in plasma (Cmax) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
|
6.37 nmol/L
Geometric Coefficient of Variation 20.6
|
6.51 nmol/L
Geometric Coefficient of Variation 19.4
|
9.66 nmol/L
Geometric Coefficient of Variation 44.5
|
8.35 nmol/L
Geometric Coefficient of Variation 27.2
|
6.25 nmol/L
Geometric Coefficient of Variation 23.1
|
6.15 nmol/L
Geometric Coefficient of Variation 22.8
|
PRIMARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
|
273 nmol*h/L
Geometric Coefficient of Variation 18.7
|
282 nmol*h/L
Geometric Coefficient of Variation 17.2
|
290 nmol*h/L
Geometric Coefficient of Variation 24.7
|
276 nmol*h/L
Geometric Coefficient of Variation 21.1
|
258 nmol*h/L
Geometric Coefficient of Variation 25.1
|
260 nmol*h/L
Geometric Coefficient of Variation 20.2
|
SECONDARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
6060 nmol*h/L
Geometric Coefficient of Variation 25.7
|
6190 nmol*h/L
Geometric Coefficient of Variation 22.5
|
6490 nmol*h/L
Geometric Coefficient of Variation 20.0
|
6300 nmol*h/L
Geometric Coefficient of Variation 18.7
|
2130 nmol*h/L
Geometric Coefficient of Variation 15.5
|
2180 nmol*h/L
Geometric Coefficient of Variation 15.4
|
SECONDARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
14100 ng*h/mL
Geometric Coefficient of Variation 29.3
|
14100 ng*h/mL
Geometric Coefficient of Variation 30.0
|
8260 ng*h/mL
Geometric Coefficient of Variation 29.2
|
8600 ng*h/mL
Geometric Coefficient of Variation 33.2
|
12200 ng*h/mL
Geometric Coefficient of Variation 25.8
|
12400 ng*h/mL
Geometric Coefficient of Variation 25.0
|
SECONDARY outcome
Timeframe: 1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administrationPopulation: PKS
Area under the concentration-time curve of the Linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented
Outcome measures
| Measure |
FDC 25 Fed (T1)
n=15 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 Participants
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 Participants
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 Participants
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 Participants
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
465 nmol*h/L
Geometric Coefficient of Variation 27.2
|
483 nmol*h/L
Geometric Coefficient of Variation 24.8
|
477 nmol*h/L
Geometric Coefficient of Variation 31.1
|
443 nmol*h/L
Geometric Coefficient of Variation 25.2
|
424 nmol*h/L
Geometric Coefficient of Variation 27.6
|
420 nmol*h/L
Geometric Coefficient of Variation 27.1
|
Adverse Events
FDC 25 Fed (T1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
E25+L5+M1000 Fed (R1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FDC 25 Fast (T2)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
E25+L5+M1000 Fast (R2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FDC 10 Fed (T3)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
E10+L5+M1000 Fed (R3)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FDC 25 Fed (T1)
n=15 participants at risk
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E25+L5+M1000 Fed (R1)
n=14 participants at risk
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 times 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
FDC 25 Fast (T2)
n=20 participants at risk
Subjects were orally administered single dose of 25 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after an overnight fast of at least 10 h
|
E25+L5+M1000 Fast (R2)
n=18 participants at risk
Subjects were orally administered single dose of free combination of 25 mg empagliflozin, 5 mg linagliptin and 2 tablets of 500 mg metformin extended release tablets with 240 mL of water after after an overnight fast of at least 10 h
|
FDC 10 Fed (T3)
n=14 participants at risk
Subjects were orally administered single dose of 10 mg empagliflozin/5 mg linagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablet with 240 mL of water after a high-fat, high-calorie breakfast
|
E10+L5+M1000 Fed (R3)
n=15 participants at risk
Subjects were orally administered single dose of free combination of 10 mg empagliflozin, 5 mg linagliptin and 2 tablets of 500 mg metformin extended release tablets with 240 mL of water after a high-fat, high-calorie breakfast
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
5.0%
1/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
6.7%
1/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
5.6%
1/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
13.3%
2/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
14.3%
2/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
5.0%
1/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
13.3%
2/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
5.6%
1/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
6.7%
1/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
7.1%
1/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
5.0%
1/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
6.7%
1/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
14.3%
2/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
15.0%
3/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
16.7%
3/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
7.1%
1/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
13.3%
2/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
7.1%
1/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
|
Skin and subcutaneous tissue disorders
Blister rupture
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
7.1%
1/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/20 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/18 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/14 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
0.00%
0/15 • Adverse events occurring up to 168 hours after intake of trial drug administration in each treatment period were assigned to treatment. Adverse events were collected up to 42 days per participant.
|
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
- Publication restrictions are in place