NCT00717145

Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Postmenopausal
• Non-lactating
• Surgically Sterile

Interventions

Type	Name	Description
DRUG	risedronate	one risedronate 20 mg DR tablet
DRUG	risedronate	One risedronate 20 mg DR tablet
DRUG	risedronate	One risedronate 35 mg DR tablet
DRUG	risedronate	One risedronate 35 mg IR tablet

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-07-16
• Last updated: 2011-10-12

Locations

3 sites across 1 country: United States