Food Effects on the Relative Bioavailability of Different Dosages of Risedronate - Full Text View

Sponsors and Collaborators:	Procter and Gamble Sanofi-Aventis
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00717145

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 I

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-availability Study
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

Further study details as provided by Procter and Gamble:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	81
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
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Experimental 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
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717145

Locations

United States, Florida
Research site
Miramar, Florida, United States
Research Site
Gainesville, Florida, United States
United States, Texas
Research Site
Austin, Texas, United States

Sponsors and Collaborators

Procter and Gamble

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Procter and Gamble Pharmaceuticals ( Chantell L. Wilson, Ph.D./ Monitor )
Study ID Numbers:	2008052
Study First Received:	July 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00717145 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

bioequivalence

Study placed in the following topic categories:

Calcium, Dietary
Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Risedronic acid

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Calcium Channel Blockers

Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Risedronic acid

ClinicalTrials.gov processed this record on May 07, 2009