A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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:

• 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

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