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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.
The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast |
|
| 2 | Active Comparator | Two risedronate 75 mg tablets administered as a single oral dose after an overnight (10 hour) fast, followed by a 4 hour post-dose fast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate | Drug | 1 risedronate 150 mg tablet administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to assess the bioequivalence of one risedronate 150 mg tablet versus two risedronate 75 mg tablets administered as a single oral dose. | 18-21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William S Aronstein, PhD/M/FACP | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gainesville | Florida | United States | |||
| Research Facility |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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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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| Risedronate |
| Drug |
2 risedronate 75 mg tablets administered as a single oral dose |
|
| Miramar |
| Florida |
| United States |
| Research Facility | Austin | Texas | United States |
| Research Facility | Dallas | Texas | United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |