Trial Outcomes & Findings for Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects. (NCT NCT02084056)
NCT ID: NCT02084056
Last Updated: 2016-08-04
Results Overview
AUC 0-72 (area under the concentration-time curve of 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.
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
This study was conducted in two parts. Part 1: Fasting study Part 2: Fed Study
Participant milestones
| Measure |
FDC 2000 Fasted / L+M 2000 Fasted
Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
L+M 2000 Fasted / FDC 2000 Fasted
Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 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 2000mg
|
FDC 2000 Fed / L+M 2000 Fed
Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
L+M 2000 Fed / FDC 2000 Fed
Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
|---|---|---|---|---|
|
Treatment Period 1 (4 Days)
STARTED
|
28
|
30
|
8
|
8
|
|
Treatment Period 1 (4 Days)
COMPLETED
|
27
|
30
|
8
|
8
|
|
Treatment Period 1 (4 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Washout Period 1 (35 Days)
STARTED
|
27
|
30
|
8
|
8
|
|
Washout Period 1 (35 Days)
COMPLETED
|
26
|
30
|
8
|
8
|
|
Washout Period 1 (35 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Treatment Period 2 (4 Days)
STARTED
|
26
|
30
|
8
|
8
|
|
Treatment Period 2 (4 Days)
COMPLETED
|
26
|
30
|
8
|
8
|
|
Treatment Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FDC 2000 Fasted / L+M 2000 Fasted
Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
L+M 2000 Fasted / FDC 2000 Fasted
Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 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 2000mg
|
FDC 2000 Fed / L+M 2000 Fed
Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
L+M 2000 Fed / FDC 2000 Fed
Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
|---|---|---|---|---|
|
Treatment Period 1 (4 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Washout Period 1 (35 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
Baseline characteristics by cohort
| Measure |
FDC 2000 Fasted or L+M 2000 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 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
L+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
FDC 2000 Fed or L+M 2000 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 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.
L+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin XR 2000mg
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 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: PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
AUC 0-72 (area under the concentration-time curve of 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 2000 Fasted
n=55 Participants
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=57 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=16 Participants
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=15 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) 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)
|
278.460 nmol*h/L
Geometric Coefficient of Variation 9.1
|
288.709 nmol*h/L
Geometric Coefficient of Variation 9.1
|
264.509 nmol*h/L
Geometric Coefficient of Variation 12.7
|
268.814 nmol*h/L
Geometric Coefficient of Variation 12.7
|
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: PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to 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 2000 Fasted
n=55 Participants
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=57 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=16 Participants
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=15 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
|
8.274 nmol/L
Geometric Coefficient of Variation 19.6
|
9.480 nmol/L
Geometric Coefficient of Variation 19.6
|
6.729 nmol/L
Geometric Coefficient of Variation 20.1
|
6.613 nmol/L
Geometric Coefficient of Variation 20.1
|
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: PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
AUC 0-tz (Area under the concentration-time curve of metformin 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 2000 Fasted
n=56 Participants
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=56 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=15 Participants
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=15 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) 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)
|
12028.27 ng*h/mL
Geometric Coefficient of Variation 17.6
|
11601.19 ng*h/mL
Geometric Coefficient of Variation 17.6
|
20411.01 ng*h/mL
Geometric Coefficient of Variation 11.7
|
19952.61 ng*h/mL
Geometric Coefficient of Variation 11.7
|
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: PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Cmax (maximum measured concentration of 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 2000 Fasted
n=56 Participants
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=57 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=15 Participants
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=15 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Cmax of Metformin in Plasma
|
1516.558 ng/mL
Geometric Coefficient of Variation 19.9
|
1485.642 ng/mL
Geometric Coefficient of Variation 19.9
|
1571.040 ng/mL
Geometric Coefficient of Variation 13.8
|
1662.954 ng/mL
Geometric Coefficient of Variation 13.8
|
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: PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints
AUC0-inf (area under the concentration-time curve of linagliptin 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 2000 Fasted
n=55 Participants
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=57 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=16 Participants
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=15 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) 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)
|
457.780 nmol*h/L
Geometric Coefficient of Variation 15.8
|
473.704 nmol*h/L
Geometric Coefficient of Variation 15.8
|
445.884 nmol*h/L
Geometric Coefficient of Variation 16.7
|
451.888 nmol*h/L
Geometric Coefficient of Variation 16.7
|
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 2000 fast and PKS 2000 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 metformin 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 2000 Fasted
n=56 Participants
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=56 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=15 Participants
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=15 Participants
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
AUC0-inf of Metformin in Plasma
|
12736.87 ng*h/mL
Geometric Coefficient of Variation 19.7
|
12162.37 ng*h/mL
Geometric Coefficient of Variation 19.7
|
20721.20 ng*h/mL
Geometric Coefficient of Variation 11.9
|
20346.34 ng*h/mL
Geometric Coefficient of Variation 11.9
|
Adverse Events
L+M 2000 Fasted
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
FDC 2000 Fasted
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
L+M 2000 Fed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
FDC 2000 Fed
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
L+M 2000 Fasted
n=56 participants at risk
5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 2000 Fasted
n=58 participants at risk
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 2000 Fed
n=16 participants at risk
5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 2000 Fed
n=16 participants at risk
5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
1.7%
1/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 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 47 days.
|
10.3%
6/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
12.5%
2/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
3/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
8.6%
5/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
25.0%
4/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
2/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
8.6%
5/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
12.5%
2/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
1.7%
1/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
General disorders
Discomfort
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
General disorders
Influenza like illness
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
3.4%
2/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 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 47 days.
|
5.2%
3/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Nervous system disorders
Headache
|
19.6%
11/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
15.5%
9/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
18.8%
3/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.8%
1/56 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/58 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
0.00%
0/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 days.
|
6.2%
1/16 • From the first drug administration for at least 7 days after the last drug administration, up to 47 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