Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Risedronate

• Registration Number: NCT00699777
• Lead Sponsor: Warner Chilcott

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.

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-02
• Study Completion: 2008-04
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-18
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Risedronate	One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
2	Risedronate	Two risedronate 75 mg tablets administered as a single oral dose after an overnight (10 hour) fast, followed by a 4 hour post-dose fast

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research Site; 🇺🇸 Gainesville, Florida, United States

Research Facility; 🇺🇸 Dallas, Texas, United States