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The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Metformin HCL Tablets, 1000 mg |
|
| 2 | Active Comparator | Glucophage 1000 mg Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin HCL Tablets, 1000 mg Sandoz | Drug |
| ||
| Glucophage 1000 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence according to US FDA guidelines | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soran Hong, M.D. | Novum Pharmaceutical Research Services | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| D004700 | Endocrine System Diseases |