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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

July 15, 2008
October 7, 2011
July 2008
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00717145 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Postmenopausal
  • Non-lactating
  • Surgically Sterile
  • 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: 1
    One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.
    Intervention: Drug: risedronate
  • 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.
    Intervention: Drug: risedronate
  • 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.
    Intervention: Drug: risedronate
  • 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.
    Intervention: Drug: risedronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Female
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717145
2008052
No
Warner Chilcott
Warner Chilcott
Sanofi
Not Provided
Warner Chilcott
October 2011

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