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The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olmesartan Medoxomil Tablets 40 mg |
|
| 2 | Active Comparator | Benicar® Tablets 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan Medoxomil Tablets 40 mg | Drug | 40mg, single dose fasting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. | blood collections through 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D Carlson, Pharm. D. | PRACS Institute Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute, Ltd. | Fargo | North Dakota | 58104 | United States |
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| Label | URL |
|---|---|
| Mylan Pharmaceuticals Inc. - Clinical Trial Results | View source |
| Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use | View source |
| Recalls, Market Withdrawals and Safety Alerts |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Benicar® Tablets 40 mg |
| Drug |
40mg, single dose fasting |
|
| View source |
| D013777 |
| Tetrazoles |