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

PHASE1CompletedINTERVENTIONAL
Enrollment

538

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Osteoporosis
Interventions
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

Trial Locations (6)

33025

Research Site, Miramar

33901

Research Site, Fort Myers

68154

Research Site, Omaha

75247

Research Site, Dallas

78752

Research site, Austin

92123

Research Site, San Diego

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Warner Chilcott

INDUSTRY

NCT00846196 - A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects | Biotech Hunter | Biotech Hunter