Status:
COMPLETED
Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food
Lead Sponsor:
Warner Chilcott
Collaborating Sponsors:
Sanofi
Conditions:
Healthy
Eligibility:
FEMALE
40-70 years
Phase:
PHASE1
Brief Summary
Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (prec...
Eligibility Criteria
Inclusion
- female, 40 to 70 years of age
- 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 :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00868907
Start Date
March 1 2009
End Date
April 1 2009
Last Update
October 12 2011
Active Locations (4)
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1
Research Site
Gainesville, Florida, United States, 32601
2
Research Site
Miami, Florida, United States, 33126
3
Research Site
Honolulu, Hawaii, United States, 96821
4
Research Site
Evansville, Indiana, United States, 47711