Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT01080365
First received: March 2, 2010
Last updated: September 3, 2010
Last verified: September 2010

March 2, 2010
September 3, 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01080365
3160A4-1120, B1871016
No
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