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Food Effects on the Relative Bioavailability of Different Dosages of Risedronate

NCT00717145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2011-10-12

No results posted yet for this study

Summary

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.

Conditions

  • Postmenopausal
  • Non-lactating
  • Surgically Sterile

Interventions

DRUG

risedronate

one risedronate 20 mg DR tablet

DRUG

risedronate

One risedronate 20 mg DR tablet

DRUG

risedronate

One risedronate 35 mg DR tablet

DRUG

risedronate

One risedronate 35 mg IR tablet

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

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 NCT00717145 on ClinicalTrials.gov