Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Risedronate (Drug); Risedronate (Drug)
Phase: Phase 1
Sponsored by: Warner Chilcott
Official(s) and/or principal investigator(s):
William S Aronstein, PhD/M/FACP, Study Director, Affiliation: Procter and Gamble
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.
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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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.
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.
Minimum age: 18 Years.
Maximum age: 50 Years.
- be in good general health based on medical history, physical examination, and
- have a body mass index (BMI) ≤ 32 kg/m2 at screening
- has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid
- 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
Locations and Contacts
Research Site, Gainesville, Florida, United States
Research Facility, Miramar, Florida, United States
Research Facility, Austin, Texas, United States
Research Facility, Dallas, Texas, United States
Starting date: January 2008
Last updated: April 15, 2013