Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

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

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

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Karyotype
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Philadelphia Chromosome
• Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

• NCT number: NCT01374139
• Study type: Interventional
• Source: Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: August 2011
• Completion date: October 2011