A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

Osteoporosis Clinical Trial

Official title:

A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00846196
• Other study ID #: 2008119
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2009
• Last updated: October 7, 2011
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: October 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• male or female, 18 to 65 years of age

• if female, non-lactating and either surgically sterile or postmenopausal

• body mass index less than or equal to 32 kg/m2 at screening

Exclusion Criteria:

• no use of a bisphosphonate within 1 month

• no history of GI disease

• no use of any medications within 7-14 days prior to scheduled dosing day

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• risedronate DR (Phase III clinical supply)
Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
• risedronate 35 mg DR (Commercial Tablet)
Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast

Locations

Country	Name	City	State
United States	Research site	Austin	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Fort Myers	Florida
United States	Research Site	Miramar	Florida
United States	Research Site	Omaha	Nebraska
United States	Research Site	San Diego	California

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	Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations.		72 hours post-dose	No