Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
A Randomized, Open-label, 2-period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects
1 other identifier
interventional
96
1 country
4
Brief Summary
This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2008
Shorter than P25 for phase_1
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
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedApril 17, 2013
April 1, 2013
1 month
June 16, 2008
April 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is to assess the bioequivalence of one risedronate 150 mg tablet versus two risedronate 75 mg tablets administered as a single oral dose.
18-21 days
Study Arms (2)
1
EXPERIMENTALOne risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
2
ACTIVE COMPARATORTwo risedronate 75 mg tablets administered as a single oral dose after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
Interventions
Eligibility Criteria
You may qualify if:
- be in good general health based on medical history, physical examination, and laboratory evaluation
- have a body mass index (BMI) ≤ 32 kg/m2 at screening
You may not qualify if:
- has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
- has any disease or surgery known to alter normal GI structure or function
- has a creatinine clearance of \< 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
- Sanoficollaborator
Study Sites (4)
Research Site
Gainesville, Florida, United States
Research Facility
Miramar, Florida, United States
Research Facility
Austin, Texas, United States
Research Facility
Dallas, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William S Aronstein, PhD/M/FACP
Procter and Gamble
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
June 16, 2008
First Posted
June 18, 2008
Study Start
January 1, 2008
Primary Completion
February 1, 2008
Study Completion
April 1, 2008
Last Updated
April 17, 2013
Record last verified: 2013-04