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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Warner Chilcott
• Collaborator: Sanofi
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

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