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:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00868907
First received: March 23, 2009
Last updated: October 7, 2011
Last verified: October 2011
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00868907     History of Changes
Other Study ID Numbers: 2008138
Study First Received: March 23, 2009
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Risedronic acid
Vitamin D
Etidronic Acid
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014