A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.

Led by Warner Chilcott · Updated on 2011-10-12

538

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility 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

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