Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2009-05-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
50 or 400 mg AZD9056, Test formulation
AZD9056 formulation Phase III 50 mg (T)
Given as 50 mg tablet (T)
AZD9056 formulation Phase III 200 mg (T)
Given as 400 mg (2 x 200 mg tablet (T))
2
50 or 400 mg AZD9056, Reference formulation
AZD9056 formulation Phase IIb 50 mg (R)
Given as 50 mg tablet (R)
AZD9056 formulation Phase IIb 200mg (R)
Given as 400 mg (2 x 200 mg tablet (R))
Interventions
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AZD9056 formulation Phase III 50 mg (T)
Given as 50 mg tablet (T)
AZD9056 formulation Phase IIb 50 mg (R)
Given as 50 mg tablet (R)
AZD9056 formulation Phase III 200 mg (T)
Given as 400 mg (2 x 200 mg tablet (T))
AZD9056 formulation Phase IIb 200mg (R)
Given as 400 mg (2 x 200 mg tablet (R))
Eligibility Criteria
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Inclusion Criteria
* Healthy Volunteers, Females should not be of childbearing potential
* BMI between 18 and 30 kg/m2
Exclusion Criteria
* A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
* Known or suspected drug or alcohol abuse or positive DOA test
18 Years
55 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Mark Layton
Role: STUDY_DIRECTOR
AstraZeneca R&D, Alderley Park, UK
Simon Constable
Role: PRINCIPAL_INVESTIGATOR
ICON Development Solutions, Manchester, UK
Locations
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Research Site
Manchester, , United Kingdom
Countries
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Other Identifiers
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EudraCT Number: 2009-010554-35
Identifier Type: -
Identifier Source: secondary_id
D1520C00004
Identifier Type: -
Identifier Source: org_study_id
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