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Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

NCT ID: NCT00717145

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Postmenopausal Non-lactating Surgically Sterile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

One risedronate 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast.

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

one risedronate 20 mg DR tablet

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.

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

One risedronate 20 mg DR tablet

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.

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

One risedronate 35 mg DR tablet

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.

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

One risedronate 35 mg IR tablet

Interventions

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risedronate

one risedronate 20 mg DR tablet

Intervention Type DRUG

risedronate

One risedronate 20 mg DR tablet

Intervention Type DRUG

risedronate

One risedronate 35 mg DR tablet

Intervention Type DRUG

risedronate

One risedronate 35 mg IR tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Gainesville, Florida, United States

Site Status

Research site

Miramar, Florida, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2008052

Identifier Type: -

Identifier Source: org_study_id