A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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A single dose of metformin 500 mg tablets
A single 50 mg tablet of sitagliptin
A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
A single dose of metformin 1000 mg tablets
The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
Time frame: 72 hours post dose
Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
Time frame: 72 hours post dose
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