Official Title: “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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: February 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Risedronate
  • 1 risedronate 150 mg tablet administered orally
• Drug: Risedronate
  • 2 risedronate 75 mg tablets administered as a single oral dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast
• 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

Primary Measures

• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

William S Aronstein, PhD/M/FACP Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699777

Study ID Number: 2007141

ClinicalTrials.gov Identifier: NCT00699777

Health Authority: United States: Food and Drug Administration