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

Sponsor

Warner Chilcott (Industry)

Overall Status

Completed

CT.gov ID

NCT00699777

Collaborator

Sanofi (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Risedronate Drug: Risedronate	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

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 Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast	Drug: Risedronate 1 risedronate 150 mg tablet administered orally
Active Comparator: 2 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	Drug: Risedronate 2 risedronate 75 mg tablets administered as a single oral dose

Arm

Intervention/Treatment

Experimental: 1

One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast

Drug: Risedronate

1 risedronate 150 mg tablet administered orally

Active Comparator: 2

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

Drug: Risedronate

2 risedronate 75 mg tablets administered as a single oral dose

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Gainesville	Florida	United States
2	Research Facility	Miramar	Florida	United States
3	Research Facility	Austin	Texas	United States
4	Research Facility	Dallas	Texas	United States

Sponsors and Collaborators

Warner Chilcott
Sanofi

Investigators

Study Director: William S Aronstein, PhD/M/FACP, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Warner Chilcott

ClinicalTrials.gov Identifier:

NCT00699777

Other Study ID Numbers:

2007141

First Posted:

Jun 18, 2008

Last Update Posted:

Apr 17, 2013

Last Verified:

Apr 1, 2013

Additional relevant MeSH terms:

Osteoporosis

Risedronic Acid

Etidronic Acid

Study Results

No Results Posted as of Apr 17, 2013