Status:
COMPLETED
Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
Lead Sponsor:
Warner Chilcott
Collaborating Sponsors:
Sanofi
Conditions:
Osteoporosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately...
Detailed Description
The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and ...
Eligibility Criteria
Inclusion
- be in good general health based on medical history, physical examination, and laboratory evaluation
- have a body mass index (BMI) ≤ 32 kg/m2 at screening
Exclusion
- has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
- has any disease or surgery known to alter normal GI structure or function
- has a creatinine clearance of \< 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00699777
Start Date
January 1 2008
End Date
April 1 2008
Last Update
April 17 2013
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Gainesville, Florida, United States
2
Research Facility
Miramar, Florida, United States
3
Research Facility
Austin, Texas, United States
4
Research Facility
Dallas, Texas, United States