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

NCT00868907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2011-10-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

35 mg risedronate DR tablet

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast and taking one Caltrate® 600+D tablet

DRUG

35 mg risedronate DR tablet

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard dinner

DRUG

35 mg risedronate DR tablet

35 mg risedronate DR oral tablet administered within 5 minutes after completing a standard breakfast

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Chantell Wilson, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868907 on ClinicalTrials.gov