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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00846196
First received: February 13, 2009
Last updated: October 7, 2011
Last verified: October 2011
History of Changes

February 13, 2009
October 7, 2011
January 2009
May 2009   (final data collection date for primary outcome measure)
Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations. [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00846196 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Osteoporosis
  • 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 Name: Phase III clinical supply
  • 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 Name: Commercial Tablet
  • Experimental: 2
    one commercial risedronate 35 mg DR tablet
    Intervention: Drug: risedronate 35 mg DR (Commercial Tablet)
  • Active Comparator: 1
    one Phase III risedronate 35 mg DR tablet
    Intervention: Drug: risedronate DR (Phase III clinical supply)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
538
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00846196
2008119
No
Warner Chilcott
Warner Chilcott
Sanofi
Study Director: Chantell Wilson, PhD Procter and Gamble
Warner Chilcott
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP