Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
Phase 1
Completed
- Conditions
- Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)
- Interventions
- Registration Number
- NCT01374139
- Lead Sponsor
- Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 Bosutinib - Cohort 2 Bosutinib -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore