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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
History of Changes
  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:

Drug Information available for: Bosutinib
U.S. FDA Resources

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 May 16, 2013