Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition

A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF BOSUTINIB PEDIATRIC CAPSULE AND THE COMMERCIAL TABLET FORMULATIONS IN HEALTHY PARTICIPANTS UNDER FED CONDITION

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.

Inclusion Criteria:

1. Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
2. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
2. Any condition possibly affecting drug absorption.