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The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| empagliflozin/linagliptin FDC | Experimental | empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| empagliflozin/linagliptin FDC | Drug | empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for Linagliptin | Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin | 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. |
| Cmax for Empagliflozin | Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin | 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. |
| AUC 0-tz for Linagliptin | 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 | 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. |
| AUC 0-tz for Empagliflozin | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-infinity for Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for linagliptin | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Sumida Hospital | Tokyo, Sumida-ku | 133-0004 | Japan |
This is a Open-label, randomised, single-dose, two-sequence, crossover design
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 + Washout |
| |||||||||||||
| Treatment Period 2 |
|
Treated Set (TS): This analysis set included all 22 randomised subjects who were documented to have taken at least 1 dose of trial medication
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax for Linagliptin | Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 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. |
|
From first drug administration until 7 days thereafter for each treatment arm, up to 8 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empagliflozin 25 mg/ Linagliptin 5 mg (Reference;Fasted) | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| AUC0-infinity for Empagliflozin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for empagliflozin. | 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. |
| AUC0-72 for Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for linagliptin | 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. |
| NOT COMPLETED |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed) | 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 |
|
|
|
| Primary | Cmax for Empagliflozin | Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 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. |
|
|
|
|
| Primary | AUC 0-tz for Linagliptin | 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 | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol∙h/L | 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. |
|
|
|
|
| Primary | AUC 0-tz for Empagliflozin | 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 | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol∙h/L | 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. |
|
|
|
|
| Secondary | AUC0-infinity for Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for linagliptin | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol∙h/L | 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. |
|
|
|
|
| Secondary | AUC0-infinity for Empagliflozin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for empagliflozin. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol∙h/L | 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. |
|
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|
|
| Secondary | AUC0-72 for Linagliptin | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for linagliptin | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol∙h/L | 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. |
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|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Empagliflozin 25 mg/ Linagliptin 5 mg (Test;Fed) | 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 | 0 | 22 | 0 | 22 |
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