Healthy Participants
Conditions
Keywords
bosutinib,, bioequivalence,, Cmax,, AUC
Brief summary
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.
Interventions
100 mg dose of bosutinib pediatric capsule
DRUGBosutinib tablet
100 mg dose of bosutinib tablet
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] | 6 days | Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0-inf)\] |
| Maximum Observed Plasma Concentration (Cmax) | 6 days | Maximum Observed Plasma Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cmax (Tmax) | 6 days | Time to Cmax (Tmax) |
| Plasma elimination half-life (t1/2) | 6 days | Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half. |
| Apparent Volume of Distribution (Vz/F) | 6 days | 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. |
| Apparent Oral Clearance (CL/F) | 6 days | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 6 days | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
Countries
Netherlands
Outcome results
None listed