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Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food

NCT ID: NCT00868907

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet

Group Type EXPERIMENTAL

35 mg risedronate DR tablet

Intervention Type DRUG

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet

Treatment B

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner

Group Type EXPERIMENTAL

35 mg risedronate DR tablet

Intervention Type DRUG

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner

Treatment C

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Group Type ACTIVE_COMPARATOR

35 mg risedronate DR tablet

Intervention Type DRUG

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Interventions

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35 mg risedronate DR tablet

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet

Intervention Type DRUG

35 mg risedronate DR tablet

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner

Intervention Type DRUG

35 mg risedronate DR tablet

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female, 40 to 70 years of age
* 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

Principal Investigators

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Chantell Wilson, PhD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Research Site

Gainesville, Florida, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Honolulu, Hawaii, United States

Site Status

Research Site

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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2008138

Identifier Type: -

Identifier Source: org_study_id