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

Study Overview
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Brief Summary
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Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Official Title
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Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Metformin
* Drug: Empagliflozin
* Drug: Empagliflozin/Metformin
* Drug: Metformin
* Drug: Empagliflozin/Metformin
* Drug: Empagliflozin
* Drug: Metformin
* Drug: Empagliflozin/Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male and female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Empagliflozin/Metformin (T)<br>fixed-dose-combination tablet, oral with 240 ml water under fasted conditions | Drug: Empagliflozin/Metformin<br>* medium dose of Empagliflozin oral administration<br>|
| Experimental: 2 Empagliflozin/Metformin (T)<br>fixed-dose-combination tablet, oral with 240 ml water under fed conditions | Drug: Empagliflozin/Metformin<br>* medium dose of Empagliflozin oral administration<br>|
| Experimental: 3 Empagliflozin + Metformin (R)<br>tablets, oral with 240 ml water under fasted conditions | Drug: Empagliflozin<br>* medium dose oral administration<br>Drug: Metformin<br>* oral administration<br>|
| Experimental: 4 Empagliflozin + Metformin (R)<br>tablets, oral with 240 ml water under fed conditions | Drug: Empagliflozin<br>* medium dose oral administration<br>Drug: Metformin<br>* oral administration<br>|
| Experimental: 5 Empagliflozin/Metformin (T)<br>fixed-dose-combination tablet, oral with 240 ml water under fed conditions | Drug: Empagliflozin/Metformin<br>* low dose of Empagliflozin<br>|
| Experimental: 6 Empagliflozin + Metformin (R)<br>tablets, oral with 240 ml water under fed conditions | Drug: Empagliflozin<br>* low dose of Empagliflozin oral administration<br>Drug: Metformin<br>* oral administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin | AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin | 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 | 
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin | AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin | 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 | 
| Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin | Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin | 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 | 
| Maximum Measured Concentration of the Analyte in Plasma, Metformin | Cmax: maximum measured concentration of the analyte in plasma for Metformin | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin | 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 | 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 | 
| Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin | 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 | 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 |