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

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 Intervention Model: Crossover Assignment Masking: None (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:

Drug Information available for: Risedronate sodium

U.S. FDA Resources

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 ]


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 (Adult, Senior)
Sexes 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


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

Keywords provided by Warner Chilcott:


bioequivalence

Additional relevant MeSH terms:


Risedronate Sodium Etidronic Acid Calcium Channel Blockers Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2017

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