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To evaluate and compare the relative bioavailability and therefore the bioequivalence of Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg Tablets of Novartis Europharm Limited, United Kingdom, in normal, healthy, adult, male human subjects under fasting conditions and to evaluate the safety and tolerability of Vildagliptin Tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin 50 mg Tablet | Experimental | 1 tablet of Vildagliptin 50 mg as single-dose administration |
|
| Galvus 50 mg Tablet | Active Comparator | 1 tablet of Galvus 50 mg (each tablet contains 50 mg Vildagliptin) as single-dose administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin 50 MG | Drug | 50 mg Vildagliptin as single-dose per study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Vildagliptin 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 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 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 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 for the test and the reference products | Plasma elimination half-life | up to 24 hours |
| Kel of Vildagliptin 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 |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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