Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
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ClinicalTrials.gov Identifier: NCT00717145 |
Recruitment Status
:
Completed
First Posted
: July 16, 2008
Last Update Posted
: October 12, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopausal Non-lactating Surgically Sterile | Drug: risedronate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
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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.
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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.
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Drug: risedronate
One risedronate 35 mg DR tablet
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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
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- 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 ]

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717145
United States, Florida | |
Research Site | |
Gainesville, Florida, United States | |
Research site | |
Miramar, Florida, United States | |
United States, Texas | |
Research Site | |
Austin, Texas, United States |
Responsible Party: | Warner Chilcott |
ClinicalTrials.gov Identifier: | NCT00717145 History of Changes |
Other Study ID Numbers: |
2008052 |
First Posted: | July 16, 2008 Key Record Dates |
Last Update Posted: | October 12, 2011 |
Last Verified: | October 2011 |
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 |