Trial Outcomes & Findings for Empa/Lina FDC Food Effect Study (Japan) (NCT NCT02815644)
NCT ID: NCT02815644
Last Updated: 2018-08-16
Results Overview
Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.
Results posted on
2018-08-16
Participant Flow
This is a Open-label, randomised, single-dose, two-sequence, crossover design
Participant milestones
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 1: Fed-Fasted)
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after a standard Japanese breakfast in period 1 and after an overnight fast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 2: Fasted-Fed)
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after an overnight fast in period 1 and after a standard Japanese breakfast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
Treatment Period 1 + Washout
STARTED
|
11
|
11
|
|
Treatment Period 1 + Washout
COMPLETED
|
11
|
11
|
|
Treatment Period 1 + Washout
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
11
|
11
|
|
Treatment Period 2
COMPLETED
|
11
|
11
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Empa/Lina FDC Food Effect Study (Japan)
Baseline characteristics by cohort
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 1: Fed-Fasted)
n=11 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after a standard Japanese breakfast in period 1 and after an overnight fast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Sequence 2: Fasted-Fed)
n=11 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after an overnight fast in period 1 and after a standard Japanese breakfast in period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.00 Years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
33.73 Years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
31.36 Years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: Pharmacokinetic Set (PKS): The PKS included all 22 randomised subjects who were documented to have taken at least 1 dose of trial medication under fed or fasted condition without having protocol deviation relevant to the evaluation of relative bioavailability and without experiencing emesis at or before 2 times median tmax.
Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
Cmax for Linagliptin
|
15.1 nmol/L
Geometric Coefficient of Variation 50.6
|
8.43 nmol/L
Geometric Coefficient of Variation 30.3
|
PRIMARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: PKS
Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
Cmax for Empagliflozin
|
1010 nmol/L
Geometric Coefficient of Variation 27.1
|
756 nmol/L
Geometric Coefficient of Variation 27.3
|
PRIMARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for linagliptin
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
AUC 0-tz for Linagliptin
|
348 nmol∙h/L
Geometric Coefficient of Variation 15.4
|
286 nmol∙h/L
Geometric Coefficient of Variation 20.5
|
PRIMARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for empagliflozin
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
AUC 0-tz for Empagliflozin
|
7210 nmol∙h/L
Geometric Coefficient of Variation 19.1
|
6200 nmol∙h/L
Geometric Coefficient of Variation 20.6
|
SECONDARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for linagliptin
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
AUC0-infinity for Linagliptin
|
597 nmol∙h/L
Geometric Coefficient of Variation 20.6
|
526 nmol∙h/L
Geometric Coefficient of Variation 33.4
|
SECONDARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for empagliflozin.
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
AUC0-infinity for Empagliflozin
|
7270 nmol∙h/L
Geometric Coefficient of Variation 19.1
|
6280 nmol∙h/L
Geometric Coefficient of Variation 20.4
|
SECONDARY outcome
Timeframe: 2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.Population: PKS
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for linagliptin
Outcome measures
| Measure |
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film coated tablet with 150 mL water after an overnight fast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
n=22 Participants
Patient were orally administered Empagliflozin 25 mg/ linagliptin 5 mg fixed-dose combination (FDC) film-coated tablet with 150 mL water after a standard Japanese breakfast in period 1 or period 2. Single-dose in each treatment period separated by wash-out period of at least 35 days
|
|---|---|---|
|
AUC0-72 for Linagliptin
|
348 nmol∙h/L
Geometric Coefficient of Variation 15.4
|
286 nmol∙h/L
Geometric Coefficient of Variation 20.5
|
Adverse Events
Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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 Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER