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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001214-25 | EudraCT Number |
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The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
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| 2 | Experimental |
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| 3 | Experimental |
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| 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 mg PF-06412562 MR tablets_Fasted | Drug | A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0-2 days | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0-2 days | |
| Time after dose and before the first plasma concentration (Tlag) | 0-2 | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf). | 0- 2 days |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | 0-2 days |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0-2 days |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 2 x 15 mg PF-06412562 MR tablets_Fasted | Drug | Two 15 mg PF-06412562 modified release tablets administered after an overnight fast |
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| 2 x 15 mg PF-06412562 MR tablets_Fed | Drug | Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast |
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| 10 mg PF-06412562 IR tablets | Drug | a single immediate release tablet of 10 mg PF-06412562 after an overnight fast |
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