Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

Pfizer88 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BosutinibDRUG

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

BosutinibDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Exclusion Criteria: * Pregnant or nursing women or women of childbearing potential.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore