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To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC |
|
| 2 | Experimental | Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC |
|
| 3 | Active Comparator | GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb |
|
| 4 | Active Comparator | GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC | Drug |
| ||
| Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 23 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So Ran Hong, M.D. | Novum Independent Institutional Review Board | Principal Investigator |
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| Drug |
|
| GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb | Drug |
|
| GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb | Drug |
|
| 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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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