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A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

NCT00846196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2011-10-12

No results posted yet for this study

Summary

Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.

Conditions

Interventions

DRUG

risedronate DR (Phase III clinical supply)

Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast

DRUG

risedronate 35 mg DR (Commercial Tablet)

Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Chantell Wilson, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00846196 on ClinicalTrials.gov