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
- 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.
- Pregnant or nursing women or women of childbearing potential.
Type of Study:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Plasma Cmax for bosutinib.
Outcome Time Frame:
96 hr post dose in each period
Pfizer CT.gov Call Center
Singapore: Health Sciences Authority (HSA)
- Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
- Bioequivalence and Food Effect Studies
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome