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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 15, 2008
Last Updated Date	October 7, 2011
Start Date ^ICMJE	July 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 15, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00717145 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Postmenopausal Non-lactating Surgically Sterile
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	94
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	40 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00717145
Other Study ID Numbers ^ICMJE	2008052
Has Data Monitoring Committee	No
Responsible Party	Warner Chilcott
Study Sponsor ^ICMJE	Warner Chilcott
Collaborators ^ICMJE	Sanofi
Investigators ^ICMJE	Not Provided
Information Provided By	Warner Chilcott
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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