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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | one commercial risedronate 35 mg DR tablet |
|
| 1 | Active Comparator | one Phase III risedronate 35 mg DR tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate DR (Phase III clinical supply) | Drug | Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations. | 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chantell Wilson, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | 92123 | United States | ||
| Research Site |
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|
| risedronate 35 mg DR (Commercial Tablet) | Drug | Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast |
|
|
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Research Site | Miramar | Florida | 33025 | United States |
| Research Site | Omaha | Nebraska | 68154 | United States |
| Research site | Austin | Texas | 78752 | United States |
| Research Site | Dallas | Texas | 75247 | United States |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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