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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023876-14 | EudraCT Number |
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The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1981 | Drug | 100 mg per oral, twice daily for 8 days |
| |
| AZD1981 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics for pravastatin measured by Cmax and AUC | Pharmacokinetics for pravastatin measured by Cmax and AUC | Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Pharmacokinetics for pravastatin measured by AUC[0-t],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT | PK sampling will be performed on Day 1, period A and on Day 7-8, period B |
| AUCτ | Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| ID | Term |
|---|---|
| C569518 | AZD1981 |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
4x100 mg per oral, twice daily for 8 days |
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| pravastatin | Drug | 40 mg, once daily at Day 1, period A and Day 8, period B |
|
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| PK sampling will be performed on Day 7 and Day 8, period B |
| Safety and tolerability | Safety and tolerability of AZD1981 | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |