Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Completed · Phase 1

Conditions studied: Postmenopausal, Non-lactating, Surgically Sterile

In brief

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.

Key facts

Study ID

NCT00717145

Run by

Warner Chilcott

People needed

94

Starts

2008-07-01

Expected to finish

2008-09-01

Last updated by the study team

2011-10-12

Who can join

Age: 40 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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 — Gainesville, Florida, United States
• Research site — Miramar, Florida, United States
• Research Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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