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A study to compare two different tablet formulations of AZD8931 in healthy males and females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg AZD8931 wet granulation tablet formulation | Active Comparator |
| |
| 40 mg AZD8931 roller compacted tablet formulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8931 | Drug | 40 mg AZD8931 wet granulation tablet formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation. | Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs). | From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Stuart | AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK | Study Director |
| Dr Darren Wilbraham, DICP, MBBS | Quintiles Drug Research Unit at Guy's Hospital | Principal Investigator |
| Jason Clark, BSc | Quintiles Drug Research Unit at Guy's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| C548875 | AZD 8931 |
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| AZD8931 | Drug | 40 mg AZD8931 roller compacted tablet formulation |
|