Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Study Overview
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Brief Summary
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To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin

Official Title
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Bioequivalence of Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Linagliptin/metformin
* Drug: Metformin
* Drug: Linagliptin


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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linagliptin/metformin<br>fixed dose combination tablet (FDC) | Drug: Linagliptin/metformin<br>* FDC<br>|
| Experimental: Linagliptin and metformin<br>single tablets | Drug: Metformin<br>* single tablet Metformin<br>Drug: Linagliptin<br>* single tablet Linagliptin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin | AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours | 
| Maximum Concentration (Cmax) of Metformin | Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin | AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours | 
| Time to Maximum Concentration (Tmax) of Metformin | Time from dosing to the maximum concentration of metformin in plasma. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours | 
| Terminal Half-life t1/2 of Metformin | The terminal half-life of metformin in plasma is denoted by t1/2. | 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours |