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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
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Postmenopausal Non-lactating Surgically Sterile Drug: risedronate Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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