Study Comparing Two Different Tablet Formulations Of Bosutinib

NCT ID: NCT00934674

Last Updated: 2009-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Commercial Tablet manufactured by Excella

Group Type EXPERIMENTAL

SKI-606 (Bosutinib)

Intervention Type DRUG

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

2

Clinical Tablet manufactured by Wyeth Montreal

Group Type EXPERIMENTAL

SKI-606 (Bosutinib)

Intervention Type DRUG

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Interventions

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SKI-606 (Bosutinib)

Arm 1 - Commercial Tablet manufactured by Excella

Arm 2 - Clinical Tablet manufactured by Wyeth Montreal

Intervention Type DRUG

Other Intervention Names

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Bosutinib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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3160A4-1115

Identifier Type: -

Identifier Source: org_study_id

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