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Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

Last updated on December 15, 2017

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

NCT01080365
Pfizer
Completed
Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

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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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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