Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate

PHASE1CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Bioavailability
Interventions
DRUG

Risedronate

Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.

DRUG

Risedronate

Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.

DRUG

Risedronate

Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.

DRUG

Risedronate

Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.

Trial Locations (3)

Unknown

Research Site, Fort Myers

Research Site, Miramar

Research Site, Austin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Warner Chilcott

INDUSTRY

NCT00755872 - Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate | Biotech Hunter | Biotech Hunter