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
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01080365

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT01080365     History of Changes
Other Study ID Numbers: 3160A4-1120, B1871016
Study First Received: March 2, 2010
Last Updated: September 3, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014