Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00699777
First received: June 16, 2008
Last updated: April 15, 2013
Last verified: April 2013

June 16, 2008
April 15, 2013
January 2008
February 2008   (final data collection date for primary outcome measure)
The primary objective is to assess the bioequivalence of one risedronate 150 mg tablet versus two risedronate 75 mg tablets administered as a single oral dose. [ Time Frame: 18-21 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699777 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects
A Randomized, Open-label, 2-period, Crossover Study to Assess the Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets Administered as a Single Oral Dose in Healthy Male and Female Subjects

This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.

The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Osteoporosis
  • Drug: Risedronate
    1 risedronate 150 mg tablet administered orally
  • Drug: Risedronate
    2 risedronate 75 mg tablets administered as a single oral dose
  • Experimental: 1
    One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
    Intervention: Drug: Risedronate
  • Active Comparator: 2
    Two risedronate 75 mg tablets administered as a single oral dose after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
    Intervention: Drug: Risedronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
April 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • be in good general health based on medical history, physical examination, and laboratory evaluation
  • have a body mass index (BMI) ≤ 32 kg/m2 at screening

Exclusion Criteria:

  • has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
  • has any disease or surgery known to alter normal GI structure or function
  • has a creatinine clearance of < 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00699777
2007141
No
Warner Chilcott
Warner Chilcott
Sanofi
Study Director: William S Aronstein, PhD/M/FACP Procter and Gamble
Warner Chilcott
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP