Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

October 7, 2011 updated by: Warner Chilcott

Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets

Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

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
    • Florida
      • Gainesville, Florida, United States
        • Research Site
      • Miramar, Florida, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • 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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
Drug: risedronate
one risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 35 mg DR tablet
Drug: risedronate
One risedronate 35 mg IR tablet
Experimental: 2
One risedronate 20 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.
Drug: risedronate
one risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 35 mg DR tablet
Drug: risedronate
One risedronate 35 mg IR tablet
Experimental: 3
One risedronate 35 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.
Drug: risedronate
one risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 35 mg DR tablet
Drug: risedronate
One risedronate 35 mg IR tablet
Experimental: 4
One risedronate 35 mg IR tablet taken following an overnight fast, 30 minutes before ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose.
Drug: risedronate
one risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 20 mg DR tablet
Drug: risedronate
One risedronate 35 mg DR tablet
Drug: risedronate
One risedronate 35 mg IR tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal.
Time Frame: 4 Days
4 Days

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

July 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008052

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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