NCT00846196

A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	risedronate DR (Phase III clinical supply)	Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
DRUG	risedronate 35 mg DR (Commercial Tablet)	Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-02-18
• Last updated: 2011-10-12

Locations

6 sites across 1 country: United States