Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
1 other identifier
interventional
94
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2008
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 15, 2008
CompletedFirst Posted
Study publicly available on registry
July 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedOctober 12, 2011
October 1, 2011
2 months
July 15, 2008
October 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
1
EXPERIMENTALOne risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
2
EXPERIMENTALOne 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
EXPERIMENTALOne 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
EXPERIMENTALOne 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.
Interventions
Eligibility Criteria
You may qualify if:
- non-lactating and either surgically sterile or postmenopausal:
- body mass index less than or equal to 32 kg/m2 at screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
- Sanoficollaborator
Study Sites (3)
Research Site
Gainesville, Florida, United States
Research site
Miramar, Florida, United States
Research Site
Austin, Texas, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2008
First Posted
July 16, 2008
Study Start
July 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
October 12, 2011
Record last verified: 2011-10