Study Assessing Dosing Time and Calcium and Vitamin D on the Relative BA of 35 mg DR Risedronate Dosed With Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 35 mg risedronate DR tablet

• Registration Number: NCT00868907
• Lead Sponsor: Warner Chilcott

Brief Summary

Randomized, open-label, single dose, 3-treatment, 3-period crossover study, with a 14- to 17-day washout period between doses. The study will consist of a screening visit, study center admission (preceding Treatment Periods 1, 2 and 3), 3 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1, 2 and 3), and exit procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• female, 40 to 70 years of age
• non-lactating and either surgically sterile or postmenopausal
• body mass index less than or equal to 32 kg/m2 at screening

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	35 mg risedronate DR tablet	35 mg risedronate DR tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet
Treatment B	35 mg risedronate DR tablet	35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner
Treatment C	35 mg risedronate DR tablet	35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Primary Outcome Measures

Name	Time	Method
Relative BA of DR Risedronate dosed: After breakfast and with calcium/vitamin D tablet, compared to DR Risedronate dosed after breakfast After dinner compared to DR Risedronate administered after breakfast.	72 hours post-dose

Trial Locations

Locations (1)

Research Site; 🇺🇸 Evansville, Indiana, United States