Study Comparing Two Different Tablet Formulations Of Bosutinib

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

NCT00934674

Enrollment

Registered

2009-07-08

Start date

2009-07-31

Completion date

2009-08-31

Last updated

2009-09-02

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

Conditions

Healthy

Keywords

Healthy Subjects

Brief summary

This study is comparing 2 formulations of bosutinib in healthy subjects.

Interventions

DRUGSKI-606 (Bosutinib)

Arm 1 - Commercial Tablet manufactured by Excella Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

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 non-childbearing potential, age 18 to 50 years.

Exclusion criteria

* Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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