Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

Study Overview
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Brief Summary
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The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.

Official Title
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A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Metformin Single Tablet
* Drug: Linagliptin/Metformin Combo
* Drug: Linagliptin Single Tablet


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: 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linagliptin/Metformin medium dosecombo<br>patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily | Drug: Linagliptin/Metformin Combo<br>* Fixed dose combination<br>|
| Active Comparator: Linagliptin plus Metformin medium dose<br>patient to receive two individual tablets: Linagliptin and Metformin (medium dose) | Drug: Metformin Single Tablet<br>* Metformin medium doseTablet<br>Drug: Linagliptin Single Tablet<br>* Linagliptin Single medium dose Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | Maximum measured concentration of metformin in plasma, per period. | Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period | 
| Area Under the Curve 0 to Last Measurable Value (AUC0-t) | AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method. | Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve 0 to Inf (AUC0-inf) | AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity. | Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period |