Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets
Overview
- Phase
- Phase 1
- Intervention
- risedronate
- Conditions
- Postmenopausal
- Sponsor
- Warner Chilcott
- Enrollment
- 94
- Locations
- 2
- Primary Endpoint
- Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •non-lactating and either surgically sterile or postmenopausal:
- •body mass index less than or equal to 32 kg/m2 at screening
Exclusion Criteria
- •No use of a bisphosphonate within 1 month
- •no history of GI disease
- •no use of any medications within 7-14 days prior to scheduled dosing day
Arms & Interventions
1
One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
Intervention: risedronate
2
One risedronate 20 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.
Intervention: risedronate
3
One risedronate 35 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.
Intervention: risedronate
4
One risedronate 35 mg IR tablet taken following an overnight fast, 30 minutes before ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.
Intervention: risedronate
Outcomes
Primary Outcomes
Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal.
Time Frame: 4 Days