Status:
COMPLETED
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Lead Sponsor:
Warner Chilcott
Collaborating Sponsors:
Sanofi
Conditions:
Osteoporosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment per...
Eligibility Criteria
Inclusion
- male or female, 18 to 65 years of age
- if female, 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 :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT00846196
Start Date
January 1 2009
End Date
May 1 2009
Last Update
October 12 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
San Diego, California, United States, 92123
2
Research Site
Fort Myers, Florida, United States, 33901
3
Research Site
Miramar, Florida, United States, 33025
4
Research Site
Omaha, Nebraska, United States, 68154