Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects - Full Text View

Sponsor:	Warner Chilcott
Collaborator:	Sanofi-Aventis
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00699777

Purpose

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	Intervention	Phase
Osteoporosis	Drug: Risedronate	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

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. [ Time Frame: 18-21 days ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	January 2008
Study Completion Date:	April 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699777

Locations

United States, Florida
Research Site
Gainesville, Florida, United States
Research Facility
Miramar, Florida, United States
United States, Texas
Research Facility
Austin, Texas, United States
Research Facility
Dallas, Texas, United States

Sponsors and Collaborators

Warner Chilcott

Sanofi-Aventis

Investigators

Study Director:

William S Aronstein, PhD/M/FACP

Procter and Gamble

More Information

No publications provided

Responsible Party:	William S Aronstein, PhD, MD, FACP, Procter & Gamble
ClinicalTrials.gov Identifier:	NCT00699777 History of Changes
Other Study ID Numbers:	2007141
Study First Received:	June 16, 2008
Last Updated:	June 13, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents

Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012