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NCT00717145 Clinical Trial

Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00717145
Other study ID # 2008052
Secondary ID
Status Completed
Phase Phase 1
First received July 15, 2008
Last updated October 7, 2011
Start date July 2008
Est. completion date September 2008

Study information
Verified date October 2011
Source Warner Chilcott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 94
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• risedronate
one risedronate 20 mg DR tablet
• risedronate
One risedronate 20 mg DR tablet
• risedronate
One risedronate 35 mg DR tablet
• risedronate
One risedronate 35 mg IR tablet

Locations
Country Name City State
United States Research Site Austin Texas
United States Research Site Gainesville Florida
United States Research site Miramar Florida

Sponsors (2)
Lead Sponsor Collaborator
Warner Chilcott Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 4 Days No
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