Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Conditions
Keywords
Bosutinib, Bioequivalence and Food Effect Studies
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).
Interventions
DRUGBosutinib
5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Cmax for bosutinib. | 96 hr post dose in each period |
| AUCt for bosutinib. | 96 hr post dose in each period |
| Plasma AUCinf for bosutinib. | 96 hr post dose in each period |
| AUClast for bosutinib. | 96 hr post dose in each period |
| Tmax for bosutinib. | 96 hr post dose in each period |
| t½ for bosutinib. | 96 hr post dose in each period |
Countries
Singapore
Outcome results
None listed