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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699777
• Other study ID #: 2007141
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2008
• Last updated: April 15, 2013
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Risedronate
1 risedronate 150 mg tablet administered orally
• Risedronate
2 risedronate 75 mg tablets administered as a single oral dose

Locations

Country	Name	City	State
United States	Research Facility	Austin	Texas
United States	Research Facility	Dallas	Texas
United States	Research Site	Gainesville	Florida
United States	Research Facility	Miramar	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No