Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.

• 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:

• non-lactating and either surgically sterile or postmenopausal:

• body mass index less than or equal to 32 kg/m2 at screening

Exclusion Criteria:

• 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