Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet |
|
| Treatment B | Experimental | 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner |
|
| Treatment C | Active Comparator | 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 35 mg risedronate DR tablet | Drug | 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast. | 72 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chantell Wilson, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gainesville | Florida | 32601 | United States | ||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 35 mg risedronate DR tablet | Drug | 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner |
|
| 35 mg risedronate DR tablet | Drug | 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast |
|
| Miami |
| Florida |
| 33126 |
| United States |
| Research Site | Honolulu | Hawaii | 96821 | United States |
| Research Site | Evansville | Indiana | 47711 | United States |
| 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 |
Not provided
Not provided