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

Completed · Phase 1

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00699777

Run by

Warner Chilcott

People needed

96

Starts

2008-01-01

Expected to finish

2008-04-01

Last updated by the study team

2013-04-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Gainesville, Florida, United States
• Research Facility — Miramar, Florida, United States
• Research Facility — Austin, Texas, United States
• Research Facility — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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