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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.
Study NCT00699777   Information provided by Procter and Gamble
First Received: June 16, 2008   Last Updated: December 15, 2008   History of Changes

June 16, 2008
December 15, 2008
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
 
 
 
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.

Phase I
Interventional
Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study
Osteoporosis
  • Drug: Risedronate
    1 risedronate 150 mg tablet administered orally
  • Drug: Risedronate
    2 risedronate 75 mg tablets administered as a single oral dose
  • 1: Experimental
    One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
    Intervention: Drug: Risedronate
  • 2: Active Comparator
    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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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
William S Aronstein, PhD, MD, FACP, Procter & Gamble
2007141
Procter and Gamble
Sanofi-Aventis
Study Director: William S Aronstein, PhD/M/FACP Procter and Gamble
Procter and Gamble
December 2008

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