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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

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ClinicalTrials.gov Identifier: NCT00868907
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : October 12, 2011
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: 35 mg risedronate DR tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

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

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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
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

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
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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
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Study Director: Chantell Wilson, PhD Procter and Gamble

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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00868907     History of Changes
Other Study ID Numbers: 2008138
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Risedronic Acid
Vitamin D
Etidronic Acid
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action