Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

Study Overview
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Brief Summary
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This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.

Official Title
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An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Sitagliptin phosphate/metformin hydrochloride FDC
* Drug: Sitagliptin phosphate
* Drug: Metformin hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is in good health is a nonsmoker is willing to follow all study guidelines Exclusion Criteria: has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant is a nursing mother is unwilling to consume the required high-fat breakfast

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Active Comparator: Sita + Met then Sita/Met FDC<br>Participants receive sitagliptin (Sita) 50 mg and metformin (Met) 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg FDC tablet administered as a single dose during Period 2. | Drug: Sitagliptin phosphate/metformin hydrochloride FDC<br>* Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.<br>Drug: Sitagliptin phosphate<br>* Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.<br>Drug: Metformin hydrochloride<br>* Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.<br>|
| Active Comparator: Sita/Met FDC then Sita + Met<br>Participants receive sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2. | Drug: Sitagliptin phosphate/metformin hydrochloride FDC<br>* Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.<br>Drug: Sitagliptin phosphate<br>* Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.<br>Drug: Metformin hydrochloride<br>* Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Serum samples were used to determine the AUC from time 0 to infinity for metformin. | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of Metformin | Serum samples were used to determine the maximum concentration for metformin. | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose |