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

October 7, 2011 updated by: Warner Chilcott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

538

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Research Site
      • Miramar, Florida, United States, 33025
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68154
        • Research Site
    • Texas
      • Austin, Texas, United States, 78752
        • Research Site
      • Dallas, Texas, United States, 75247
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2
one commercial risedronate 35 mg DR tablet
Drug: 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
Other Names:
  • Commercial Tablet
ACTIVE_COMPARATOR: 1
one Phase III risedronate 35 mg DR tablet
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
Other Names:
  • Phase III clinical supply

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations.
Time Frame: 72 hours post-dose
72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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