| June 16, 2008 |
| December 15, 2008 |
| January 2008 |
| February 2008 (final data collection date for primary outcome measure) |
| 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. [ Time Frame: 18-21 days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00699777 on ClinicalTrials.gov Archive Site |
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| Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects |
| A Randomized, Open-Label, 2-Period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects |
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. |
| Phase I |
| Interventional |
| Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
| Osteoporosis |
| Drug: Risedronate |
- Experimental: One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
- 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
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| Completed |
| 96 |
| April 2008 |
| February 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- be in good general health based on medical history, physical examination, and laboratory evaluation
- have a body mass index (BMI) ≤ 32 kg/m2 at screening
Exclusion Criteria:
- has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
- has any disease or surgery known to alter normal GI structure or function
- has a creatinine clearance of < 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula
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| Both |
| 18 Years to 50 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00699777 |
| William S Aronstein, PhD, MD, FACP, Procter & Gamble |
| 2007141 |
| Procter and Gamble |
| Sanofi-Aventis |
| Study Director: |
William S Aronstein, PhD/M/FACP |
Procter and Gamble |
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| Procter and Gamble |
| December 2008 |