Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

September 3, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects

Study comparing 2 formulations of bosutinib in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98418
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women of nonchildbearing potential age 18 to 50 years

Exclusion Criteria:

  • Any clinically significant medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Commercial Tablet
Drug: SKI-606 (Bosutinib)
500 mg commercial formulation film coated tablet, administered once daily
Other Names:
  • Bosutinib
Drug: SKI-606 (Bosutinib)
500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
Other Names:
  • Bosutinib
Experimental: 2
Clinical Tablet
Drug: SKI-606 (Bosutinib)
500 mg commercial formulation film coated tablet, administered once daily
Other Names:
  • Bosutinib
Drug: SKI-606 (Bosutinib)
500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
Other Names:
  • Bosutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 3160A4-1120
  • B1871016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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