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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021956-24 | EudraCT Number |
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The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | AZD1981, low dose, + Warfarin |
|
| Treatment B | Experimental | AZD1981, high dose, + Warfarin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1981 | Drug | 100 mg per oral, twice daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC) | PK sampling will be performed regularly from Day 1 to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Explore possible changes in the anticoagulative activity of Warfarin measured by INR . | Will be performed at screening and at all visits during the study period. | |
| Pharmacokinetics for AZD1981 measured by AUCÏ„, Css,max, tmax,ss and CLss/F | PK sampling will be performed regularly from Day 15 to Day 22. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christer Hultqvist, MD | AstraZeneca | Study Director |
| Aslak Rautio | Quintiles AB | Principal Investigator |
| Wofgang Kühn, MD | Quintiles AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| ID | Term |
|---|---|
| C569518 | AZD1981 |
| D014859 | Warfarin |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin |
| Drug |
10 x 2.5 mg per oral, once daily at day 1 and day 15 |
|
|
| AZD1981 | Drug | 4 x 100 mg per oral, twice daily for 14 days |
|
| Safety and tolerability of AZD1981 | Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study. |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010847 | Picolines |
| D011725 | Pyridines |