Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects

Warner Chilcott

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: Risedronate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00699777

2007141

Details and patient eligibility

About

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 320 subjects will be enrolled from 4 study centers in the U.S.

Full 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 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.

Enrollment

96 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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