Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00868907

Run by

Warner Chilcott

People needed

101

Starts

2009-03-01

Expected to finish

2009-04-01

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…

• female, 40 to 70 years of age
• 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 — Miami, Florida, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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