Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

NCT01080365

Last updated date
Study Location
Pfizer Investigational Site
Tacoma, Washington, 98418, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any clinically significant medical condition

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions
Official Title  ICMJE A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects
Brief Summary Study comparing 2 formulations of bosutinib in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: SKI-606 (Bosutinib)
    500 mg commercial formulation film coated tablet, administered once daily
    Other Name: Bosutinib
  • Drug: SKI-606 (Bosutinib)
    500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
    Other Name: Bosutinib
Study Arms  ICMJE
  • Experimental: 1
    Commercial Tablet
    Intervention: Drug: SKI-606 (Bosutinib)
  • Experimental: 2
    Clinical Tablet
    Intervention: Drug: SKI-606 (Bosutinib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2010)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2010)
32
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Any clinically significant medical condition
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01080365
Other Study ID Numbers  ICMJE 3160A4-1120
B1871016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP