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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699777
First Posted: June 18, 2008
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
June 16, 2008
June 18, 2008
April 17, 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 ]
Same as current
Complete list of historical versions of study NCT00699777 on ClinicalTrials.gov Archive Site
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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
Intervention Model: Crossover Assignment
Masking: None (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
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*   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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00699777
2007141
No
Not Provided
Not Provided
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
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