Study Comparing Two Different Tablet Formulations Of Bosutinib

September 1, 2009 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

This study is comparing 2 formulations of bosutinib in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

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 non-childbearing potential, age 18 to 50 years.

Exclusion Criteria:

  • Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

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 manufactured by Excella
Drug: SKI-606 (Bosutinib)

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Other Names:
  • Bosutinib
Experimental: 2
Clinical Tablet manufactured by Wyeth Montreal
Drug: SKI-606 (Bosutinib)

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Other Names:
  • Bosutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics as measured by Cmax, AUC, tmax, and 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

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

July 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3160A4-1115

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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