Study Comparing Two Different Tablet Formulations Of Bosutinib

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SKI-606 (Bosutinib)

Drug

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Other names: Bosutinib

Primary outcomes

Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2

Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Single Dose Bioequivalence Study Comparing the Commercial Tablet Formulation to the Clinical Tablet of Bosutinib in Healthy Subjects

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 8, 2009
Registry last updated: Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed