Status:
COMPLETED
Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
Lead Sponsor:
Warner Chilcott
Collaborating Sponsors:
Sanofi
Conditions:
Postmenopausal
Non-lactating
Eligibility:
FEMALE
40-70 years
Phase:
PHASE1
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 treatme...
Eligibility Criteria
Inclusion
- non-lactating and either surgically sterile or postmenopausal:
- body mass index less than or equal to 32 kg/m2 at screening
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00717145
Start Date
July 1 2008
End Date
September 1 2008
Last Update
October 12 2011
Active Locations (3)
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1
Research Site
Gainesville, Florida, United States
2
Research site
Miramar, Florida, United States
3
Research Site
Austin, Texas, United States