Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Neoplasms by Histologic Type

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Chronic Disease

Disease Attributes

Translocation, Genetic

Chromosome Aberrations

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Bosutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

Spots Global Cancer Trial Database for philadelphia chromosome positive (ph+) chronic myeloid leukemia (cml)