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Philadelphia Chromosome

Neoplasms by Histologic Type

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Bosutinib

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5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition

4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition

Pfizer CT.gov Call Center

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).

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

Pfizer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects	NCT01374139	Philadelphia Ch...	Bosutinib Bosutinib	21 Years - 55 Years	Pfizer
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects	NCT01374139	Philadelphia Ch...	Bosutinib Bosutinib	21 Years - 55 Years	Pfizer

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