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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCt nr 2008-003626-41 |
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The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | simvastatin |
|
| Period 2 | Experimental | simvastatin + AZD9056 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin | Drug | One single dose of 40mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PK variables | Frequent sampling occasions during study periods |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, blood pressure, pulse, safety lab) | During the whole treatment periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rod Hepburn | AstraZeneca R&D, Charnwood, UK | Study Director |
| Maura Fallon | PAREXEL Clinical Pharmacology Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| C000608601 | AZD9056 |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| AZD9056 + simvastatin | Drug | AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7 |
|
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |