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The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm, fixed sequence dosing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration curve of simvastatin and simvastatin acid | 10 days | |
| Maximum observed plasma concentration of simvastatin and simvastatin acid | 10 days | |
| Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed | 10 days | |
| If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time | 10 days | |
| If the data permit, terminal elimination half-life of simvastatin and simvastatin acid | 10 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 Investigational Site | South Miami | Florida | 33143 | United States |
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| PF-05175157 | Drug | Days 2-9 inclusive: daily dosing of PF-05175157 200 mg |
|
| 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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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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