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Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080365
First Posted: March 4, 2010
Last Update Posted: September 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
March 2, 2010
March 4, 2010
September 6, 2010
February 2010
March 2010   (Final data collection date for primary outcome measure)
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2 [ Time Frame: 2 weeks ]
Same as current
Complete list of historical versions of study NCT01080365 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • 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
  • Experimental: 1
    Commercial Tablet
    Intervention: Drug: SKI-606 (Bosutinib)
  • Experimental: 2
    Clinical Tablet
    Intervention: Drug: SKI-606 (Bosutinib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any clinically significant medical condition
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01080365
3160A4-1120
B1871016
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2010

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