Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
Status:
Completed
Trial end date:
2021-01-15
Target enrollment:
Participant gender:
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.