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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431A-095 | |||
| 2009_636 |
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A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | 50 mg sitagliptin and 500 mg metformin as individual tablets |
|
| Treatment B | Experimental | sitagliptin/metformin 50 mg/500 mg tablet |
|
| Treatment C | Active Comparator | 50 mg sitagliptin and 1000 mg metformin as individual tablets |
|
| Treatment D | Experimental | sitagliptin/metformin 50 mg/1000 mg tablet |
|
| Treatment E | Active Comparator | 50 mg sitagliptin and 850 mg metformin as individual tablets |
|
| Treatment F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate (+) metformin hydrochloride | Drug | place holder - do not post |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. | Up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. | Up to 72 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| Experimental |
sitagliptin/metformin 50 mg/850 mg tablet |
|
| Comparator: metformin 500mg |
| Drug |
A single dose of metformin 500 mg tablet |
|
|
| Comparator: sitagliptin | Drug | A single dose of 50 mg sitagliptin tablet |
|
|
| Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet | Drug | A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet |
|
| Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet | Drug | A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet |
|
| Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet | Drug | A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet |
|
| Comparator: metformin 1000 mg | Drug | A single dose of metformin 1000 mg tablet |
|
|
| Comparator: metformin 850 mg | Drug | A single dose of metformin 850 mg tablet |
|
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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