NCT00868907

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

A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	35 mg risedronate DR tablet	35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet
DRUG	35 mg risedronate DR tablet	35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner
DRUG	35 mg risedronate DR tablet	35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-03-25
• Last updated: 2011-10-12

Locations

4 sites across 1 country: United States