Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
This study has been completed.
Sponsor:
Warner Chilcott
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00717145
First received: July 15, 2008
Last updated: October 7, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopausal Non-lactating Surgically Sterile |
Drug: risedronate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets |
Resource links provided by NLM:
Further study details as provided by Warner Chilcott:
Primary Outcome Measures:
- 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. [ Time Frame: 4 Days ] [ Designated as safety issue: No ]
| Enrollment: | 94 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
|
Drug: risedronate
one risedronate 20 mg DR tablet
|
|
Experimental: 2
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.
|
Drug: risedronate
One risedronate 20 mg DR tablet
|
|
Experimental: 3
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.
|
Drug: risedronate
One risedronate 35 mg DR tablet
|
|
Experimental: 4
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.
|
Drug: risedronate
One risedronate 35 mg IR tablet
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- non-lactating and either surgically sterile or postmenopausal:
- body mass index less than or equal to 32 kg/m2 at screening
Exclusion Criteria:
- No use of a bisphosphonate within 1 month
- no history of GI disease
- no use of any medications within 7-14 days prior to scheduled dosing day
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717145
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717145
Locations
| United States, Florida | |
| Research Site | |
| Gainesville, Florida, United States | |
| Research site | |
| Miramar, Florida, United States | |
| United States, Texas | |
| Research Site | |
| Austin, Texas, United States | |
Sponsors and Collaborators
Warner Chilcott
Sanofi
More Information
| Responsible Party: | Warner Chilcott |
| ClinicalTrials.gov Identifier: | NCT00717145 History of Changes |
| Other Study ID Numbers: | 2008052 |
| Study First Received: | July 15, 2008 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Warner Chilcott:
|
bioequivalence |
Additional relevant MeSH terms:
|
Risedronate Sodium Etidronic Acid Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016