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:
Warner Chilcott
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 23, 2013