Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00717145
• Date of registration: 15/07/2008
• Primary sponsor: Warner Chilcott
• Public title: Food Effects on the Relative Bioavailability of Different Dosages of Risedronate
• Scientific 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
• Date of first enrolment: July 2008
• Target sample size: 94
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00717145
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Non-lactating

Postmenopausal

Surgically Sterile

Intervention(s)

Drug: risedronate

Primary Outcome(s)

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]

Secondary ID(s)

2008052

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi-Aventis