Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Study Overview
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Brief Summary
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Randomized, open-label, multi-center, 4-treatment, 4-period crossover study. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2, 3, and 4), 4 treatment periods (4 days each), 3 washout periods (14 to 17 days in duration separating each treatment period), and exit procedures.

Official Title
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Food Effects on the Relative Bioavailability of a Risedronate 20 mg Delayed-release [DR] Tablet and to Compare the 20 mg DR Tablet to 35 mg DR and 35 mg Immediate-release Tablets

Conditions
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Postmenopausal, Non-lactating, Surgically Sterile

Intervention / Treatment
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* Drug: risedronate
* Drug: risedronate
* Drug: risedronate
* Drug: risedronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-lactating and either surgically sterile or postmenopausal: body mass index less than or equal to 32 kg/m2 at screening Exclusion Criteria: No use of a bisphosphonate within 1 month no history of GI disease no use of any medications within 7-14 days prior to scheduled dosing day

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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 20 mg DR tablet taken following an overnight fast, followed by a 4-hour fast. | Drug: risedronate<br>* one risedronate 20 mg DR tablet<br>|
| Experimental: 2<br>One risedronate 20 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. | Drug: risedronate<br>* One risedronate 20 mg DR tablet<br>|
| Experimental: 3<br>One risedronate 35 mg DR tablet taken following an overnight fast, within 5 minutes after ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. | Drug: risedronate<br>* One risedronate 35 mg DR tablet<br>|
| Experimental: 4<br>One risedronate 35 mg IR tablet taken following an overnight fast, 30 minutes before ingesting a high-fat meal; no additional food will be allowed for at least 4 hours post-dose. | Drug: risedronate<br>* One risedronate 35 mg IR tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the relative bioavailability of the risedronate 20 mg DR tablet administered immediately after a high-fat meal compared to the risedronate 35 mg IR tablet administered 30 minutes prior to a high-fat meal. |  | 4 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence