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

Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Risedronate (Drug); Risedronate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Procter and Gamble

Official(s) and/or principal investigator(s):
William S Aronstein, PhD/M/FACP, Study Director, Affiliation: Procter and Gamble

Summary

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.

Clinical Details

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

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

Primary outcome: 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.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Gainesville, Florida, United States

Research Facility, Miramar, Florida, United States

Research Facility, Dallas, Texas, United States

Research Facility, Austin, Texas, United States

Additional Information

Starting date: January 2008
Ending date: April 2008
Last updated: June 16, 2008

Page last updated: June 20, 2008

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