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

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT00846196
Collaborator
Sanofi (Industry)
538
Enrollment
6
Locations
2
Arms
3.9
Duration (Months)
89.7
Patients Per Site
22.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: risedronate DR (Phase III clinical supply)
  • Drug: risedronate 35 mg DR (Commercial Tablet)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
538 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Official Title:
A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations. [72 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site San Diego California United States 92123
    2 Research Site Fort Myers Florida United States 33901
    3 Research Site Miramar Florida United States 33025
    4 Research Site Omaha Nebraska United States 68154
    5 Research site Austin Texas United States 78752
    6 Research Site Dallas Texas United States 75247

    Sponsors and Collaborators

    • Warner Chilcott
    • Sanofi

    Investigators

    • Study Director: Chantell Wilson, PhD, Procter and Gamble

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Warner Chilcott
    ClinicalTrials.gov Identifier:
    NCT00846196
    Other Study ID Numbers:
    • 2008119
    First Posted:
    Feb 18, 2009
    Last Update Posted:
    Oct 12, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Osteoporosis
    Risedronic Acid
    Etidronic Acid

    Study Results

    No Results Posted as of Oct 12, 2011