Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 2-Way Crossover Bioequivalence Study To Compare The Bosutinib Clinical Tablet And Clinical Capsule And To Investigate Food Effect On Bosutinib Commercial Formulation in Healthy Subjects
1 other identifier
interventional
88
1 country
1
Brief Summary
The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedNovember 30, 2011
November 1, 2011
2 months
June 7, 2011
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Plasma Cmax for bosutinib.
96 hr post dose in each period
AUCt for bosutinib.
96 hr post dose in each period
Plasma AUCinf for bosutinib.
96 hr post dose in each period
AUClast for bosutinib.
96 hr post dose in each period
Tmax for bosutinib.
96 hr post dose in each period
t½ for bosutinib.
96 hr post dose in each period
Study Arms (2)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALInterventions
5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition
Eligibility Criteria
You may qualify if:
- Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive.
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests.
You may not qualify if:
- Pregnant or nursing women or women of childbearing potential.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 15, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 30, 2011
Record last verified: 2011-11