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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet
35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner
35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Evansville, Indiana, United States
Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast.
Time frame: 72 hours post-dose
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