Spots Global Cancer Trial Database for Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

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Trial Identification

Brief Title: Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Official Title: 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

Study ID: NCT01374139

Conditions

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

Interventions

Bosutinib

Study Description

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).

Detailed Description: