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

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

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.

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