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To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to Roerig's 10 mg Glucotrol tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.) |
|
| 2 | Active Comparator | Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.) | Drug |
| ||
| Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger D. Anderson, M.D. | Biodecision, Inc. | Principal Investigator |
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| 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 |
|---|---|
| D005913 | Glipizide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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