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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast. |
|
| 2 | Experimental | One risedronate 20 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. |
|
| 3 | Experimental | One risedronate 35 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. |
|
| 4 | Experimental | One risedronate 35 mg IR tablet taken following an overnight fast, 30 minutes before ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate | Drug | one risedronate 20 mg DR tablet |
| |
| risedronate |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal. | 4 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gainesville | Florida | United States | |||
| Research site |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Drug |
One risedronate 20 mg DR tablet |
|
| risedronate | Drug | One risedronate 35 mg DR tablet |
|
| risedronate | Drug | One risedronate 35 mg IR tablet |
|
| Miramar |
| Florida |
| United States |
| Research Site | Austin | Texas | United States |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |