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Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

NCT ID: NCT01374139

Last Updated: 2011-11-30

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia (CML)

Keywords

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Bosutinib Bioequivalence and Food Effect Studies

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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Cohort 1

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition

Cohort 2

Group Type EXPERIMENTAL

Bosutinib

Intervention Type DRUG

4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition

Interventions

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Bosutinib

5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition

Intervention Type DRUG

Bosutinib

4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition

Intervention Type DRUG

Other Intervention Names

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SKI-606, PF-05208763 SKI-606, PF-05208763

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871035&StudyName=Bioequivalence%20And%20Food%20Effect%20Study%20Of%20Bosutinib%20In%20Healthy%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1871035

Identifier Type: -

Identifier Source: org_study_id