Trial Outcomes & Findings for Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together (NCT NCT01811953)

NCT ID: NCT01811953

Last Updated: 2015-07-27

Results Overview

AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
• Results posted on: 2015-07-27

Participant Flow

Participant milestones

Measure	Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Low Dose Emp: Emp/Met / Emp+Met fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Low Dose Emp: Emp+Met / Emp/Met free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)
Overall Study STARTED	6	6	6	6	12	12
Overall Study COMPLETED	6	6	6	5	11	11
Overall Study NOT COMPLETED	0	0	0	1	1	1

Reasons for withdrawal

Measure	Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Low Dose Emp: Emp/Met / Emp+Met fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Low Dose Emp: Emp+Met / Emp/Met free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)
Overall Study Adverse Event	0	0	0	1	0	1
Overall Study Protocol Violation	0	0	0	0	1	0

Baseline Characteristics

Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together

Baseline characteristics by cohort

Measure	Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed n=6 Participants fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted n=6 Participants fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed n=6 Participants free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted n=6 Participants free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Low Dose Emp: Emp/Met / Emp+Met n=12 Participants fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Low Dose Emp: Emp+Met / Emp/Met n=12 Participants free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)	Total n=48 Participants Total of all reporting groups
Age, Continuous	33.5 years STANDARD_DEVIATION 6.7 • n=5 Participants	26.5 years STANDARD_DEVIATION 9.7 • n=7 Participants	28.5 years STANDARD_DEVIATION 9.5 • n=5 Participants	33.2 years STANDARD_DEVIATION 7.1 • n=4 Participants	32.8 years STANDARD_DEVIATION 9.8 • n=21 Participants	32.3 years STANDARD_DEVIATION 9.6 • n=10 Participants	31.5 years STANDARD_DEVIATION 8.9 • n=115 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=10 Participants	25 Participants n=115 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	23 Participants n=115 Participants

PRIMARY outcome

Timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Population: Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin

Outcome measures

Measure	1 Empagliflozin/Metformin (T) n=23 Participants fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 Participants tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=22 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=22 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin	2810 nmol*h/L Geometric Coefficient of Variation 19.3	2580 nmol*h/L Geometric Coefficient of Variation 20.4	2760 nmol*h/L Geometric Coefficient of Variation 20.0	2570 nmol*h/L Geometric Coefficient of Variation 20.7	988 nmol*h/L Geometric Coefficient of Variation 16.2	927 nmol*h/L Geometric Coefficient of Variation 18.0

PRIMARY outcome

Timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Population: PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin

Outcome measures

Measure	1 Empagliflozin/Metformin (T) n=23 Participants fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 Participants tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=22 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=21 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin	10400 ng*h/mL Geometric Coefficient of Variation 23.0	9220 ng*h/mL Geometric Coefficient of Variation 26.4	11000 ng*h/mL Geometric Coefficient of Variation 26.8	9140 ng*h/mL Geometric Coefficient of Variation 22.9	9080 ng*h/mL Geometric Coefficient of Variation 32.7	9060 ng*h/mL Geometric Coefficient of Variation 26.7

PRIMARY outcome

Timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Population: PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin

Outcome measures

Measure	1 Empagliflozin/Metformin (T) n=23 Participants fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 Participants tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=22 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=22 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin	379 nmol/L Geometric Coefficient of Variation 23.7	276 nmol/L Geometric Coefficient of Variation 24.8	375 nmol/L Geometric Coefficient of Variation 27.3	258 nmol/L Geometric Coefficient of Variation 28.5	108 nmol/L Geometric Coefficient of Variation 16.9	103 nmol/L Geometric Coefficient of Variation 14.5

PRIMARY outcome

Timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Population: PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

Cmax: maximum measured concentration of the analyte in plasma for Metformin

Outcome measures

Measure	1 Empagliflozin/Metformin (T) n=23 Participants fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 Participants tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=22 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=21 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Maximum Measured Concentration of the Analyte in Plasma, Metformin	1580 ng/mL Geometric Coefficient of Variation 26.9	1160 ng/mL Geometric Coefficient of Variation 17.8	1680 ng/mL Geometric Coefficient of Variation 25.8	1180 ng/mL Geometric Coefficient of Variation 21.2	1180 ng/mL Geometric Coefficient of Variation 23.8	1150 ng/mL Geometric Coefficient of Variation 24.8

SECONDARY outcome

Timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Population: PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin

Outcome measures

Measure	1 Empagliflozin/Metformin (T) n=23 Participants fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 Participants tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=22 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=22 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin	2770 nmol*h/L Geometric Coefficient of Variation 19.2	2530 nmol*h/L Geometric Coefficient of Variation 20.1	2720 nmol*h/L Geometric Coefficient of Variation 20.0	2510 nmol*h/L Geometric Coefficient of Variation 20.2	962 nmol*h/L Geometric Coefficient of Variation 16.3	903 nmol*h/L Geometric Coefficient of Variation 18.2

SECONDARY outcome

Timeframe: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Population: PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.

AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin

Outcome measures

Measure	1 Empagliflozin/Metformin (T) n=23 Participants fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 Participants tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=22 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=21 Participants fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 Participants tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin	10100 ng*h/mL Geometric Coefficient of Variation 21.3	8960 ng*h/mL Geometric Coefficient of Variation 24.5	10700 ng*h/mL Geometric Coefficient of Variation 24.1	8930 ng*h/mL Geometric Coefficient of Variation 22.5	8870 ng*h/mL Geometric Coefficient of Variation 30.8	8850 ng*h/mL Geometric Coefficient of Variation 26.3

Adverse Events

1 Empagliflozin/Metformin (T)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

2 Empagliflozin/Metformin (T)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

3 Empagliflozin + Metformin (R)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

4 Empagliflozin + Metformin (R)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

5 Empagliflozin/Metformin (T)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

6 Empagliflozin + Metformin (R)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1 Empagliflozin/Metformin (T) n=23 participants at risk fixed-dose-combination tablet, oral with 240 ml water under fasted conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	2 Empagliflozin/Metformin (T) n=24 participants at risk fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: medium dose of Empagliflozin oral administration	3 Empagliflozin + Metformin (R) n=24 participants at risk tablets, oral with 240 ml water under fasted conditions Empagliflozin: medium dose oral administration Metformin: oral administration	4 Empagliflozin + Metformin (R) n=24 participants at risk tablets, oral with 240 ml water under fed conditions Empagliflozin: medium dose oral administration Metformin: oral administration	5 Empagliflozin/Metformin (T) n=23 participants at risk fixed-dose-combination tablet, oral with 240 ml water under fed conditions Empagliflozin/Metformin: low dose of Empagliflozin	6 Empagliflozin + Metformin (R) n=23 participants at risk tablets, oral with 240 ml water under fed conditions Empagliflozin: low dose of Empagliflozin oral administration Metformin: oral administration
Infections and infestations Nasopharyngitis	4.3% 1/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	8.3% 2/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.2% 1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.
Nervous system disorders Headache	17.4% 4/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	8.3% 2/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.2% 1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	13.0% 3/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	17.4% 4/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.
Gastrointestinal disorders Diarrhoea	8.7% 2/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	12.5% 3/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.2% 1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	16.7% 4/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	17.4% 4/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	26.1% 6/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.
Gastrointestinal disorders Nausea	4.3% 1/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.2% 1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	13.0% 3/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.3% 1/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.
Gastrointestinal disorders Vomiting	4.3% 1/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.2% 1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	4.2% 1/24 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	8.7% 2/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.	0.00% 0/23 • From first trial medication intake until next intake or the end-of-trial visit, 10 days Adverse Evens were reported for all patients who received the specific treatment.

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place