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Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01080365
Recruitment Status : Completed
First Posted : March 4, 2010
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
Study comparing 2 formulations of bosutinib in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: SKI-606 (Bosutinib) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib

Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT01080365     History of Changes
Other Study ID Numbers: 3160A4-1120
B1871016
First Posted: March 4, 2010    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010