Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2021-01-15

Brief Summary

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This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Open Label

Study Groups

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Bosutinib capsule

Bosutinib pediatric capsule to healthy participants

Group Type EXPERIMENTAL

Bosutinib capsule

Intervention Type DRUG

100 mg dose of bosutinib pediatric capsule

Bosutinib tablet

Bosutinib tablet to healthy participants

Group Type ACTIVE_COMPARATOR

Bosutinib tablet

Intervention Type DRUG

100 mg dose of bosutinib tablet

Interventions

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Bosutinib capsule

100 mg dose of bosutinib pediatric capsule

Intervention Type DRUG

Bosutinib tablet

100 mg dose of bosutinib tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
2. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
2. Any condition possibly affecting drug absorption.

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes