Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food
A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet
1 other identifier
interventional
101
1 country
4
Brief Summary
Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), 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 healthy
Started Mar 2009
Shorter than P25 for phase_1 healthy
4 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
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedOctober 12, 2011
October 1, 2011
1 month
March 23, 2009
October 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast.
72 hours post-dose
Study Arms (3)
Treatment A
EXPERIMENTAL35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet
Treatment B
EXPERIMENTAL35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner
Treatment C
ACTIVE COMPARATOR35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast
Interventions
35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet
Eligibility Criteria
You may qualify if:
- female, 40 to 70 years of age
- 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 (4)
Research Site
Gainesville, Florida, 32601, United States
Research Site
Miami, Florida, 33126, United States
Research Site
Honolulu, Hawaii, 96821, United States
Research Site
Evansville, Indiana, 47711, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chantell Wilson, PhD
Procter and Gamble
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 25, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
October 12, 2011
Record last verified: 2011-10