This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: March 2, 2010
Last updated: September 3, 2010
Last verified: September 2010
Study comparing 2 formulations of bosutinib in healthy subjects.

Condition Intervention Phase
Healthy Drug: SKI-606 (Bosutinib) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2 [ Time Frame: 2 weeks ]

Enrollment: 31
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Commercial Tablet
Drug: SKI-606 (Bosutinib)
500 mg commercial formulation film coated tablet, administered once daily
Other Name: Bosutinib
Experimental: 2
Clinical Tablet
Drug: SKI-606 (Bosutinib)
500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
Other Name: Bosutinib


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Any clinically significant medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01080365

United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT01080365     History of Changes
Other Study ID Numbers: 3160A4-1120
Study First Received: March 2, 2010
Last Updated: September 3, 2010 processed this record on September 21, 2017