A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
NCT ID: NCT00846196
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
538 participants
INTERVENTIONAL
2009-01-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
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2
one commercial risedronate 35 mg DR tablet
risedronate 35 mg DR (Commercial Tablet)
Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
1
one Phase III risedronate 35 mg DR tablet
risedronate DR (Phase III clinical supply)
Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
Interventions
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risedronate DR (Phase III clinical supply)
Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
risedronate 35 mg DR (Commercial Tablet)
Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* if female, non-lactating and either surgically sterile or postmenopausal
* body mass index less than or equal to 32 kg/m2 at screening
Exclusion Criteria
* no history of GI disease
* no use of any medications within 7-14 days prior to scheduled dosing day
18 Years
65 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Chantell Wilson, PhD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Site
San Diego, California, United States
Research Site
Fort Myers, Florida, United States
Research Site
Miramar, Florida, United States
Research Site
Omaha, Nebraska, United States
Research site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Countries
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Other Identifiers
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2008119
Identifier Type: -
Identifier Source: org_study_id