Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

Warner Chilcott94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Postmenopausal Non-lactating Surgically Sterile

Interventions

risedronateDRUG

one risedronate 20 mg DR tablet

risedronateDRUG

One risedronate 20 mg DR tablet

risedronateDRUG

One risedronate 35 mg DR tablet

risedronate

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Gainesville, Florida, United States

Research site

Miramar, Florida, United States

Research Site

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 Days

Data from ClinicalTrials.gov

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