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

Pfizer66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

Bosutinib capsuleDRUG

100 mg dose of bosutinib pediatric capsule

Bosutinib tabletDRUG

100 mg dose of bosutinib tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 54 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

PRA Health Sciences

Groningen, Netherlands

PRA Health Sciences Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]

Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0-inf)\]

Time frame: 6 days

Maximum Observed Plasma Concentration (Cmax)

Time frame: 6 days

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time frame: 6 days

Time to Cmax (Tmax)

Time frame: 6 days

Apparent Oral Clearance (CL/F)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

Time frame: 6 days

Apparent Volume of Distribution (Vz/F)

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Time frame: 6 days

Plasma elimination half-life (t1/2)

Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 6 days

Data from ClinicalTrials.gov

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