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

Pfizer1 site in 1 country88 target enrollmentAugust 2011

ConditionsPhiladelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

InterventionsBosutinib

DrugsBosutinib

Overview

Phase: Phase 1
Intervention: Bosutinib
Conditions: Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Sponsor: Pfizer
Enrollment: 88
Locations: 1
Primary Endpoint: Plasma Cmax for bosutinib.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.