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Clinical Trial Summary

This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04549480
Study type Interventional
Source Pfizer
Status Completed
Phase Phase 1
Start date September 16, 2020
Completion date January 15, 2021

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