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

Completed · Phase 1

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00846196

Run by

Warner Chilcott

People needed

538

Starts

2009-01-01

Expected to finish

2009-05-01

Last updated by the study team

2011-10-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — San Diego, California, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Miramar, Florida, United States
• Research Site — Omaha, Nebraska, United States
• Research site — Austin, Texas, United States
• Research Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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