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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868907
First Posted: March 25, 2009
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
  Purpose
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.

Condition Intervention Phase
Healthy Drug: 35 mg risedronate DR tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: March 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 dinner
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868907


Locations
United States, Florida
Research Site
Gainesville, Florida, United States, 32601
Research Site
Miami, Florida, United States, 33126
United States, Hawaii
Research Site
Honolulu, Hawaii, United States, 96821
United States, Indiana
Research Site
Evansville, Indiana, United States, 47711
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Chantell Wilson, PhD Procter and Gamble
  More Information

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00868907     History of Changes
Other Study ID Numbers: 2008138
First Submitted: March 23, 2009
First Posted: March 25, 2009
Last Update Posted: October 12, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Vitamin D
Risedronate Sodium
Etidronic Acid
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action