NCT00755872

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

Influence of a High-fat Meal on the Bioavailability of a Two Different Formulations of Risedronate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study. Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and have urine collected over 72 hours following administration of risedronate for all 4 treatment periods).

Conditions

• Bioavailability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-09-19
• Last updated: 2011-10-12

Locations

3 sites across 1 country: United States