Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

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.

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Key information

Conditions

Postmenopausal Non-lactating Surgically Sterile

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

Drug

one risedronate 20 mg DR tablet

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

Sanofi

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jul 16, 2008
Registry last updated: Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed