Trial Outcomes & Findings for Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects (NCT NCT02121509)
NCT ID: NCT02121509
Last Updated: 2016-08-04
Results Overview
Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Results posted on
2016-08-04
Participant Flow
The study is conducted in two parts: Part 1 of the study was conducted in fasting conditions. Part 2 of the study was conducted in fed conditions.
Participant milestones
| Measure |
FDC 1500 Fasted / L+M 1500 Fasted
Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
L+M 1500 Fasted / FDC 1500 Fasted
Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
FDC 1500 Fed / L+M 1500 Fed
Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
L+M 1500 Fed / FDC 1500 Fed
Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
|---|---|---|---|---|
|
Treatment Period-1 (4 Days)
STARTED
|
30
|
28
|
8
|
8
|
|
Treatment Period-1 (4 Days)
COMPLETED
|
30
|
28
|
8
|
8
|
|
Treatment Period-1 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (35 Days)
STARTED
|
30
|
28
|
8
|
8
|
|
Washout Period (35 Days)
COMPLETED
|
28
|
24
|
8
|
8
|
|
Washout Period (35 Days)
NOT COMPLETED
|
2
|
4
|
0
|
0
|
|
Treatment Period-2 (4 Days)
STARTED
|
28
|
24
|
8
|
8
|
|
Treatment Period-2 (4 Days)
COMPLETED
|
28
|
24
|
8
|
8
|
|
Treatment Period-2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FDC 1500 Fasted / L+M 1500 Fasted
Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
L+M 1500 Fasted / FDC 1500 Fasted
Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
FDC 1500 Fed / L+M 1500 Fed
Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
L+M 1500 Fed / FDC 1500 Fed
Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
|---|---|---|---|---|
|
Washout Period (35 Days)
Adverse Event
|
1
|
1
|
0
|
0
|
|
Washout Period (35 Days)
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
|
Washout Period (35 Days)
elevated AST and ALT levels
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
Baseline characteristics by cohort
| Measure |
FDC 1500 Fasted or L+M 1500 Fasted
n=58 Participants
The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted\_R fasted or R fasted\_T fasted.
FDC 1500 fasted (T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
L+M 1500 fasted (R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
FDC 1500 Fed or L+M 1500 Fed
n=16 Participants
The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed\_R fed or R fed\_T fed.
FDC 1500 fed (T fed): 5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after after a high-fat, high-calorie meal.
L+M 1500 fed (R fed): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 1500mg
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS1500 Fast and PKS1500 Fed, included all treated subjects in Part 1 and Part 2, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC 0-72 (area under the concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1500 Fasted
n=55 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=52 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=14 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
|
298.982 nmol*h/L
Geometric Coefficient of Variation 11.5
|
307.320 nmol*h/L
Geometric Coefficient of Variation 11.5
|
257.932 nmol*h/L
Geometric Coefficient of Variation 6.6
|
261.680 nmol*h/L
Geometric Coefficient of Variation 6.6
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1500 Fasted
n=56 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=53 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=14 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
|
8.909 nmol/L
Geometric Coefficient of Variation 23.5
|
9.464 nmol/L
Geometric Coefficient of Variation 23.5
|
6.729 nmol/L
Geometric Coefficient of Variation 13.3
|
7.181 nmol/L
Geometric Coefficient of Variation 13.3
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic 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) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1500 Fasted
n=55 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=53 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=15 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
10414.62 ng*h/mL
Geometric Coefficient of Variation 25.5
|
10626.51 ng*h/mL
Geometric Coefficient of Variation 25.5
|
19434.46 ng*h/mL
Geometric Coefficient of Variation 10.7
|
18727.47 ng*h/mL
Geometric Coefficient of Variation 10.7
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1500 Fasted
n=56 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=54 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=15 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Cmax of Metformin in Plasma
|
1245.262 ng/mL
Geometric Coefficient of Variation 29.4
|
1308.777 ng/mL
Geometric Coefficient of Variation 29.4
|
1526.907 ng/mL
Geometric Coefficient of Variation 7.2
|
1739.311 ng/mL
Geometric Coefficient of Variation 7.2
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin. The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1500 Fasted
n=55 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=52 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=14 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
499.020 nmol*h/L
Geometric Coefficient of Variation 17.5
|
506.245 nmol*h/L
Geometric Coefficient of Variation 17.5
|
430.765 nmol*h/L
Geometric Coefficient of Variation 8.7
|
458.042 nmol*h/L
Geometric Coefficient of Variation 8.7
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC0-inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin. The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1500 Fasted
n=55 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=53 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 Participants
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=15 Participants
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
AUC0-inf of Metformin in Plasma
|
10831.52 ng*h/mL
Geometric Coefficient of Variation 25.0
|
11055.51 ng*h/mL
Geometric Coefficient of Variation 25.0
|
19706.52 ng*h/mL
Geometric Coefficient of Variation 10.7
|
19073.16 ng*h/mL
Geometric Coefficient of Variation 10.7
|
Adverse Events
L+M 1500 Fasted
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
FDC 1500 Fasted
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
L+M 1500 Fed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
FDC 1500 Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
L+M 1500 Fasted
n=56 participants at risk
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1500 Fasted
n=54 participants at risk
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1500 Fed
n=16 participants at risk
5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1500 Fed
n=16 participants at risk
5 mg linagliptin/1500 mg metformin XR (given as 2\*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
3/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
11.1%
6/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
7.4%
4/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
1.9%
1/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
General disorders
Fatigue
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
5.6%
3/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
3/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
1.9%
1/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
7.4%
4/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
12.5%
2/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Nervous system disorders
Headache
|
16.1%
9/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
16.7%
9/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
43.8%
7/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/54 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 43 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
- Publication restrictions are in place