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
Phase 1
21 Years
55 Years
21 Years
55 Years
Not Enrolling
Both
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Both
Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Plasma Cmax for bosutinib.
Outcome Time Frame:
96 hr post dose in each period
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Singapore: Health Sciences Authority (HSA)
Study ID:
B1871035
NCT ID:
NCT01374139
Start Date:
August 2011
Completion Date:
October 2011
Related Keywords:
- Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
- Bosutinib
- Bioequivalence and Food Effect Studies
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
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