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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002782-34 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosutinib capsule | Experimental | Bosutinib pediatric capsule to healthy participants |
|
| Bosutinib tablet | Active Comparator | Bosutinib tablet to healthy participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib capsule | Drug | 100 mg dose of bosutinib pediatric capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | 6 days |
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 6 days |
| Time to Cmax (Tmax) | Time to Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands | |||
| PRA Health Sciences Utrecht |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| C471992 | bosutinib |
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Open Label
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| Bosutinib tablet |
| Drug |
100 mg dose of bosutinib tablet |
|
| 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. | 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. | 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. | 6 days |
| Utrecht |
| 3584 BL |
| Netherlands |