At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, 4-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY TO COMPARE THE BIOAVAILABILITY OF ORALLY ADMINISTERED BOSUTINIB CAPSULES AND TO ESTIMATE THE EFFECT OF FOOD ON BOSUTINIB CAPSULE
In Brief
A Phase 1 clinical trial evaluating Bosutinib capsule and Bosutinib for Healthy Participants. Completed, enrolled 32 participants across 1 site.
Detailed Summary
This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100 mg capsule of bosutinib relative to fasted condition in adults healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extend of absorption (Cmax, AUC). Statistical analyses will be performed after the administration of a single 100 mg dose under fed condition as the Reference treatment and the four 25 mg capsules as the Test treatment for the first comparison, and after administration of a single 100 mg dose under fasted condition as the Reference treatment and the 100 mg capsule under fed condition as the Test treatment for the second comparison.
Study Details
Timeline
Interventions
Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast
Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast
Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours
Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast