Clinical Trial: Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
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 Summary:
Sponsor: Pfizer
Current Primary Outcome:
- Plasma Cmax for bosutinib. [ Time Frame: 96 hr post dose in each period ]
- AUCt for bosutinib. [ Time Frame: 96 hr post dose in each period ]
- Plasma AUCinf for bosutinib. [ Time Frame: 96 hr post dose in each period ]
- AUClast for bosutinib. [ Time Frame: 96 hr post dose in each period ]
- Tmax for bosutinib. [ Time Frame: 96 hr post dose in each period ]
- t½ for bosutinib. [ Time Frame: 96 hr post dose in each period ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Pfizer
Dates:
Date Received: June 7, 2011
Date Started: August 2011
Date Completion:
Last Updated: November 28, 2011
Last Verified: November 2011
