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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001405-40 | EudraCT Number |
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This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Bosutinib | Drug | a single dose of 500 mg oral bosutinib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration | 96 hours |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
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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 |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington Fields | Nottingham | NG11 6JS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29058816 | Derived | Hsyu PH, Pignataro DS, Matschke K. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study. Clin Pharmacol Drug Dev. 2018 May;7(4):373-381. doi: 10.1002/cpdd.396. Epub 2017 Oct 23. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C471992 | bosutinib |
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| Intravenous infusion of bosutinib |
| Drug |
a single dose of 120 mg of bosutinib intravenous infusion (1 hour) |
|
| 96 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to Reach Maximum Observed Plasma Concentration | 96 hours |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 96 hours |
| Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 96 hours |
| Volume of Distribution at Steady State (Vss) | 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 blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 96 hours |