Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Bosutinib In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01080365

Enrollment

Registered

2010-03-04

Start date

2010-02-28

Completion date

2010-03-31

Last updated

2010-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Study comparing 2 formulations of bosutinib in healthy subjects.

Interventions

DRUGSKI-606 (Bosutinib)

500 mg commercial formulation film coated tablet, administered once daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Men or women of nonchildbearing potential age 18 to 50 years

Exclusion criteria

* Any clinically significant medical condition

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics, as measured by Cmax, AUC, tmax, t1/2	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026