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Trial record 1 of 1 for:    NCT00934674
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Study Comparing Two Different Tablet Formulations Of Bosutinib

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ClinicalTrials.gov Identifier: NCT00934674
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE July 2, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE July 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2 [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Two Different Tablet Formulations Of Bosutinib
Official Title  ICMJE A Single Dose Bioequivalence Study Comparing the Commercial Tablet Formulation to the Clinical Tablet of Bosutinib in Healthy Subjects
Brief Summary This study is 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)

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Other Name: Bosutinib
Study Arms  ICMJE
  • Experimental: 1
    Commercial Tablet manufactured by Excella
    Intervention: Drug: SKI-606 (Bosutinib)
  • Experimental: 2
    Clinical Tablet manufactured by Wyeth Montreal
    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
Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT00934674
Other Study ID Numbers  ICMJE 3160A4-1115
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2009

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