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Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00717145
First received: July 15, 2008
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Postmenopausal
Non-lactating
Surgically Sterile
Drug: risedronate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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 35 mg DR 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 35 mg IR tablet

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717145

Locations
United States, Florida
Research Site
Gainesville, Florida, United States
Research site
Miramar, Florida, United States
United States, Texas
Research Site
Austin, Texas, United States
Sponsors and Collaborators
Warner Chilcott
Sanofi
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00717145     History of Changes
Other Study ID Numbers: 2008052
Study First Received: July 15, 2008
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
bioequivalence

Additional relevant MeSH terms:
Etidronic Acid
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014