Completed
A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.
Led by Warner Chilcott · Updated on 2011-10-12
538
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Warner Chilcott
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.
CONDITIONS
Brief Title
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
Trial Site Locations
Total: 6 locations
1
Research Site
San Diego, California, United States, 92123
Status Unknown
2
Research Site
Fort Myers, Florida, United States, 33901
Status Unknown
3
Research Site
Miramar, Florida, United States, 33025
Status Unknown
4
Research Site
Omaha, Nebraska, United States, 68154
Status Unknown
5
Research site
Austin, Texas, United States, 78752
Status Unknown
6
Research Site
Dallas, Texas, United States, 75247
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
N/A
Number of Arms
2
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