A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females
NCT ID: NCT01330758
Last Updated: 2011-07-29
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
26 participants
INTERVENTIONAL
2011-04-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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40 mg AZD8931 wet granulation tablet formulation
AZD8931
40 mg AZD8931 wet granulation tablet formulation
40 mg AZD8931 roller compacted tablet formulation
AZD8931
40 mg AZD8931 roller compacted tablet formulation
Interventions
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AZD8931
40 mg AZD8931 wet granulation tablet formulation
AZD8931
40 mg AZD8931 roller compacted tablet formulation
Eligibility Criteria
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Inclusion Criteria
* Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
* Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
* Male subjects must be willing to use barrier methods of contraception
* Be willing and able to comply with study procedures, restrictions and requirements
Exclusion Criteria
* Any clinically significant abnormalities at screening
* Use of any prescribed or non-prescribed medication within 2 weeks
* Receipt of another NCE or participation in any other clinical trial within 3 months
* Subjects who have previously received AZD8931
18 Years
55 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Mary Stuart
Role: STUDY_DIRECTOR
AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK
Dr Darren Wilbraham, DICP, MBBS
Role: PRINCIPAL_INVESTIGATOR
Quintiles Drug Research Unit at Guy's Hospital
Jason Clark, BSc
Role: STUDY_DIRECTOR
Quintiles Drug Research Unit at Guy's Hospital
Locations
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Research Site
London, , United Kingdom
Countries
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Other Identifiers
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D0102C00005
Identifier Type: -
Identifier Source: org_study_id