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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 35 mg risedronate DR tablet; Drug: 35 mg risedronate DR tablet; Drug: 35 mg risedronate DR tablet

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32601
      • Research Site
    • Miami, Florida, United States, 33126
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96821
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47711
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; 35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet	Drug: 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; Drug: 35 mg risedronate DR tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner; Drug: 35 mg risedronate DR tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast
Experimental: Treatment B; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner	Drug: 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; Drug: 35 mg risedronate DR tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner; Drug: 35 mg risedronate DR tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast
Active Comparator: Treatment C; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast	Drug: 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; Drug: 35 mg risedronate DR tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner; Drug: 35 mg risedronate DR tablet; 35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	72 hours post-dose

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 7, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid; Etidronic Acid
• Other Study ID Numbers: 2008138