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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Risedronate
* Drug: Risedronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>One risedronate 150 mg tablet administered orally after an overnight (10 hour) fast, followed by a 4 hour post-dose fast | Drug: Risedronate<br>* 1 risedronate 150 mg tablet administered orally<br>|
| Active Comparator: 2<br>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 | Drug: Risedronate<br>* 2 risedronate 75 mg tablets administered as a single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 18-21 days |