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The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05175157 PIC in fed state | Experimental | 200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal). |
|
| PF-05175157 tablet in fed state | Experimental | 200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). |
|
| PF-05175157 tablet in fed state (repeat) | Experimental | 200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). |
|
| PF-05175157 tablet in fasted state | Experimental | 200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05175157 | Drug | Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0 to 72 H after dose | |
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) | 0 to 72 H after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0 to 72 H after dose | |
| Time at which maximum plasma concentration is observed (Tmax) | 0 to 72 H after dose | |
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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 Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-05175157 | Drug | Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg) |
|
| PF-05175157 | Drug | Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg) |
|
| PF-05175157 | Drug | Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg) |
|
| Plasma Decay Half-Life (t1/2) |
| 0 to 72 H after dose |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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