Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

Study Overview
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Brief Summary
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The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Official Title
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Relative Bioavailability of 25 mg BI 10773 (Final Formulation) Compared to 25 mg BI 10773 XX (Trial Formulation 2) Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 10773 XX (Trial Formulation 2)
* Drug: BI 10773 (Final Formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male and female subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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?
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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: BI 10773 Final Formulation<br>one single film-coated tablet in the morning | Drug: BI 10773 (Final Formulation)<br>* one single film-coated tablet in the morning<br>|
| Experimental: BI 10773 XX Trial Formulation 2<br>one single dose tablet in the morning | Drug: BI 10773 XX (Trial Formulation 2)<br>* one single dose tablet in the morning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. Note the standard deviation is actually the coefficient of variation (CV (%)). | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | 
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of empagliflozin (empa) in plasma. Note the standard deviation is actually the CV (%). | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point. Note the standard deviation is actually the CV (%). | 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration |