Empa/Lina FDC Food Effect Study (Japan)

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Effect of Food on the Bioavailability of Empagliflozin / Linagliptin Fixed Dose Combination Tablet in an Open, Randomised, Single Dose, Two Way Cross-over Study in Healthy Japanese Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: empagliflozin/linagliptin FDC


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male subjects age >=20 and <=45 years; body weight: >=50 kg and <=80 kg; body mass index: >=18.0 and <=25.0 kg/m2 Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature) Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation Exclusion criteria: Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance Further exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: empagliflozin/linagliptin FDC<br>empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet | Drug: empagliflozin/linagliptin FDC<br>* empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |