Clinical trial · Interventional
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects
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 Commercial Formulation in Healthy Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosutinib | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- interventionNames
- Drug: Bosutinib
- type
- EXPERIMENTAL
- label
- Cohort 2
- interventionNames
- Drug: Bosutinib
Primary outcomes (6)
- measure
- Plasma Cmax for bosutinib.
- timeFrame
- 96 hr post dose in each period
- measure
- AUCt for bosutinib.
- timeFrame
- 96 hr post dose in each period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive. * Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests. Exclusion Criteria: * Pregnant or nursing women or women of childbearing potential.
References
Publications (0)
Data not yet available