Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Phase 1

Completed

• Conditions: Postmenopausal; Non-lactating; Surgically Sterile
• Interventions: Drug: risedronate

• Registration Number: NCT00717145
• Lead Sponsor: Warner Chilcott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	risedronate	One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
2	risedronate	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.
3	risedronate	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.
4	risedronate	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.

Primary Outcome Measures

Name	Time	Method
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.	4 Days

Trial Locations

Locations (2)

Research Site; 🇺🇸 Austin, Texas, United States

Research site; 🇺🇸 Miramar, Florida, United States