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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

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

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

Treatment and study plan

35 mg risedronate DR tablet

Drug

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

Primary outcomes

Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast.

Time frame: 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

Sanofi

Registry information

Official study title

A Crossover Study to Assess the Relative BA of Delayed-release Risedronate Compared When Dosed With Either Dinner, Breakfast or Breakfast Plus a Calcium/Vitamin D Tablet

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 25, 2009
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