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
-
-
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
|
500 mg commercial formulation film coated tablet, administered once daily
Other Names:
500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
Other Names:
|
|
Experimental: 2
Clinical Tablet
|
500 mg commercial formulation film coated tablet, administered once daily
Other Names:
500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
Other Names:
|
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.
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.
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.