Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Warner Chilcott
With
Sanofi
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 an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
