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To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/1000 mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin and Vildagliptin 1000/50 mg Tablet | Experimental | 1 tablet of Metformin and Vildagliptin 1000/50 mg as single-dose administration |
|
| EUCREAS® 50/1000 mg Tablet | Active Comparator | 1 tablet of EUCREAS® 50/1000 mg (each film-coated tablet contains Vildagliptin 50 mg and Metformin hydrochloride 1000 mg) as single-dose administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin and Vildagliptin 1000/50 mg | Drug | 50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Vildagliptin and Metformin for the test and reference products | The maximum concentration in plasma among observed concentrations at pre-specified time points | up to 24 hours |
| AUC0-t of Vildagliptin and Metformin for the test and the reference products | The area under the plasma concentration versus time curve from time 0 to the last measured concentration | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ of Vildagliptin and Metformin for the test and the reference products | The area under the plasma concentration versus time curve from time 0 to to infinite time | up to 24 hours |
| Tmax of Vildagliptin and Metformin for the test and the reference products |
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Inclusion Criteria:
Exclusion Criteria:
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The time to maximum measured plasma concentration |
| up to 24 hours |
| T1/2 of Vildagliptin and Metfomin for the test and the reference products | Plasma elimination half-life | up to 24 hours |
| Kel of Vildagliptin and Metformin for the test and the reference products | Elimination rate constant | up to 24 hours |
| Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol | An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment. | through study completion, an average of 1 month |
| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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