Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Risedronate (Drug); Risedronate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Procter and Gamble Official(s) and/or principal investigator(s):
William S Aronstein, PhD/M/FACP, Study Director, Affiliation: Procter and Gamble
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.
Clinical Details
Official title: 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
Study design: Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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.
Detailed description:
The data to support the interchangeability of one risedronate 150 mg tablet versus two
risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in
vitro dissolution and an in vivo study, which showed risedronate absorption is not
dissolution rate limited. These results suggest that monthly dosing of risedronate may be
accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75
mg tablets. The purpose of this study is to provide additional clinical data to support the
interchangeability of these 2 dose regimens.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Research Site, Gainesville, Florida, United States
Research Facility, Miramar, Florida, United States
Research Facility, Dallas, Texas, United States
Research Facility, Austin, Texas, United States
Additional Information
Starting date: January 2008
Ending date: April 2008
Last updated: June 16, 2008
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