A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00846196
First received: February 13, 2009
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.


Condition Intervention Phase
Osteoporosis
Drug: risedronate DR (Phase III clinical supply)
Drug: risedronate 35 mg DR (Commercial Tablet)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Crossover Study to Assess the Bioequivalence of the Phase III and Commercial Risedronate 35 mg Delayed Release Formulations.

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Assess the bioequivalence (BE) between the commercial and the Phase III risedronate 35 mg DR formulations. [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 538
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
one commercial risedronate 35 mg DR tablet
Drug: risedronate 35 mg DR (Commercial Tablet)
Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
Other Name: Commercial Tablet
Active Comparator: 1
one Phase III risedronate 35 mg DR tablet
Drug: risedronate DR (Phase III clinical supply)
Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
Other Name: Phase III clinical supply

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female, 18 to 65 years of age
  • if female, 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846196

Locations
United States, California
Research Site
San Diego, California, United States, 92123
United States, Florida
Research Site
Fort Myers, Florida, United States, 33901
Research Site
Miramar, Florida, United States, 33025
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68154
United States, Texas
Research site
Austin, Texas, United States, 78752
Research Site
Dallas, Texas, United States, 75247
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: NCT00846196     History of Changes
Other Study ID Numbers: 2008119
Study First Received: February 13, 2009
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014